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-II BLADE L95 TAN 04.027.054S manufactured by Synthes Bettlach.
[87680002]
(b)(4). Complainant part is not expected to be returned for manufacturer review/investigation. Device is not distributed in the united states, but is similar to device marketed in the usa. He investigation could not be completed; no conclusion could be drawn, as no product was received. Device history record (dhr): manufacturing location: (b)(4). Manufacturing date: 03. Apr. 2017. Expiry date: 01. Mar. 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. (b)(4). 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
[87680003]
Device report from synthes europe reports an event in (b)(6)as follows: the reported devices were used in the surgery for the femoral trochanteric fracture on (b)(6) 2017. At the third week after the surgery, the cut-out occurred; thus, the blade penetrated the femoral head. According the surgeon? S opinion, the reduction was performed well during the surgery, and the postoperative x-ray images were fine. The surgeon also stated that the revision surgery (possible bipolar hip arthroplasty bha) must be considered if the blade penetration progresses. At this moment, natural bone healing is expected by the surgeon. Patient outcome ok. Concomitant devices: 1x 472. 102s / 9820495 (pfna-ii? 11 xs 125? L170 tan), 1x 459. 360vs / 5941663 (bolt? 4. 9 self-tap l36 tav green), 1x 473. 170s / l382493 (pfna-ii end cap extens. 0 tan). This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612488-2017-10495 |
| MDR Report Key | 6901224 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-09-28 |
| Date of Report | 2017-09-07 |
| Date of Event | 2017-09-07 |
| Date Mfgr Received | 2017-11-10 |
| Device Manufacturer Date | 2017-04-03 |
| 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-II BLADE L95 TAN |
| Generic Name | APPLIANCE,FIXATION,NAIL/BLADE/ PLATE COMBO, SINGLE COMPONENT |
| Product Code | KTW |
| Date Received | 2017-09-28 |
| Catalog Number | 04.027.054S |
| Lot Number | L365872 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Required No Informationntervention | 2017-09-28 |