MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-02-09 for PHILOS 3.5 3HO TI 441.901S manufactured by Oberdorf : Synthes Produktions Gmbh.
[100051182]
A device history record review was performed for the subject device: part number: 441. 901s. Synthes lot number: l348868. Release to warehouse date: 20. Apr. 2017, expiry date: 01. Apr. 2027. Manufacturing site: (b)(4). No ncrs were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. A product development investigation was performed for the subject device: 1x 441. 901s / l348868 philos 3. 5 3ho ti sent to manufacturing plant raron for investigation: stains and scratches are visible on the surface. A dhr review was performed. The following work orders lead to the finished product: semi-finished product: l344237. Work order was printed on march 3th 2017 and released on march 9th 2017. Nothing unusual happened; the full lot (120 parts) was produced and found to be in specification. Finished product: l348868. Work order was printed on march 8 th 2017 and released for sale on april 20th 2017. Nothing unusual happened; the full lot (20 parts) was produced and found to be in specification. Investigation of critical features during production: this complaint is about the thread hole in the shaft part of the plate. The critical feature in regards to the complaint is the thread zero point measurement of the thread hole. The inspection measures the thread zero point and at the same time it is a functional test of the conical thread. Investigation of critical features on complaint part: the critical features were verified on the complaint part. All measurements taken align with the results on the tests and measurements performed during production. All measurements of the measurable features were found to be in specifications. Raw material: the plate is manufactured out of the following raw-material: sheet 3. 20mm ticp has / article # 60010275 / lot # 19267. The raw-material certificate is attached in attachment 2. It is found to be in specification. Conclusion: the plate (article # 441. 901s (philos 3. 5 3lo ti) / lot # l348868) was produce as it should. No abnormality in process was found. No manufacturing related issue was identified and/or confirmed, therefore review to the specific prm and prm line is not applicable. X-ray review did show that a screw had been backed out. Therefore, complaint is confirmed. The material was determined to be conforming at the time of manufacture based on review of the dhr. Replication of the complaint via functional test was not able to be performed at customer quality (cq) due to post manufacturing wear consistent with implantation and explantation. Drawings were reviewed and no product design issues or discrepancies were observed. Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[100051183]
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that the device was used in original surgery for proximal humeral fracture on (b)(6) 2017. When the 70-to-80-year-old female patient underwent the surgery, the proximal humeral plate was applied. As the patient complained pain on the fractured area, it was found on (b)(6) that a screw (part number unknown) had been backed out of the plate. The backed-out screw and the plate were explanted, and then other implants were implanted. The procedure was completed successfully. The x-rays (date of x-rays unknown), shows the screw migrated. Concomitant device: a 1x lockscr? 3. 5 self-tap l42 tan , 412-118s / l343717, 1x lockscr? 3. 5 self-tap l40 tan, 412-117s / l416285, 1x lockscr? 3. 5 self-tap l38 tan, 412-116s / l295107, 1x lockscr? 3. 5 self-tap l36 tan, 412-115s / l329484, 1x lockscr? 3. 5 self-tap l36 tan, 412-115s / l384891, 1x lockscr? 3. 5 self-tap l32 tan, 412-112s / l186802, 1x lockscr? 3. 5 self-tap l30 tan, 412-111s / l339589, 1x lockscr? 3. 5 self-tap l28 tan, 412-110s / l432454, 1x lockscr? 3. 5 self-tap l26 tan, 412-109s / l347791. This report is for 1 unknown screws trauma. This is report 3 of 3 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2018-51012 |
| MDR Report Key | 7260980 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-02-09 |
| Date of Report | 2018-02-09 |
| Date of Event | 2017-11-09 |
| Date Mfgr Received | 2018-02-09 |
| Device Manufacturer Date | 2017-04-20 |
| Date Added to Maude | 2018-02-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHT LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | WERK RARON (CH) |
| Manufacturer Street | KANALSTRASSE WEST 30 |
| Manufacturer City | RARON 3942 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 3942 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PHILOS 3.5 3HO TI |
| Generic Name | APPLIANCE,FIXATION,NAIL/BLADE/ PLATE COMBO, SINGLE COMPONENT |
| Product Code | KTW |
| Date Received | 2018-02-09 |
| Returned To Mfg | 2017-11-27 |
| Catalog Number | 441.901S |
| Lot Number | L348868 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OBERDORF : SYNTHES PRODUKTIONS GMBH |
| Manufacturer Address | EIMATTSTRASSE 3 OBERDORF SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-09 |