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 2017-09-28 for PFNA BLADE PERF L105 SST 02.027.036S manufactured by Synthes Bettlach.
[87628905]
(b)(4). (b)(6). Device is not distributed in the united states, but is similar to device marketed in the usa. The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. Device history record (dhr): 02. 027. 036s / l512064. Manufacturing location: (b)(4). Manufacturing date: 09. Aug. 2017 expiry date: 01. Aug. 2027. 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. 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
[87628906]
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that it was not possible to tighten the proximal femoral nail anti-rotation (pfna) blade after the insertion. For the unlocking the key for the blade was used. The blade is still in the hospital for decontamination. Surgery was successfully completed with another pfna blade and a prolongation of 15 minutes. No further surgery is required. Concomitant parts: 1x key for pfna blade, 356. 832/ lot unknown; 1x impactor f/pfna blade, 03. 010. 410 / lot unknown; 1x pfna blade, perforated, l 105mm, 02. 027. 036s / lot unknown. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612488-2017-10493 |
| MDR Report Key | 6900551 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-09-28 |
| Date of Report | 2017-09-11 |
| Date of Event | 2017-09-11 |
| Date Mfgr Received | 2017-11-27 |
| Device Manufacturer Date | 2017-08-09 |
| Date Added to Maude | 2017-09-28 |
| 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 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | SYNTHES BETTLACH |
| Manufacturer Street | MURACHERSTRASSE 3 |
| Manufacturer City | BETTLACH CH2544 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH2544 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PFNA BLADE PERF L105 SST |
| Generic Name | APPLIANCE,FIXATION,NAIL/BLADE/ |
| Product Code | KTW |
| Date Received | 2017-09-28 |
| Returned To Mfg | 2017-09-18 |
| Catalog Number | 02.027.036S |
| Lot Number | L512064 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES BETTLACH |
| Manufacturer Address | MURACHERSTRASSE 3 BETTLACH CH2544 SZ CH2544 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 1 | 2017-09-28 |