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 2017-10-27 for PFNA-II BLADE L90 TAN 04.027.053S manufactured by Synthes Bettlach.
[91128835]
(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. A device history record review was performed for the subject device lot number l459694. Manufacturing location: (b)(4). Date of manufacture: 21. Jun. 2017. Expiration date: 01. Jun. 2027. The review showed that there were no issues during the manufacture or sterilization of the product that would contribute to this complaint condition. No non-conformances were generated during the production or sterilization of the subject device. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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
[91128836]
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that the reported device was used in the surgery on the femoral trochanter on (b)(6) 2017. During the procedure, the blade interfered with the nail. As a result, the blade was broken. No delay in surgery or adverse consequence to the patient was reported. The procedure was successfully completed. Concomitant device: 1x 472. 100s / 9889163 (pfna-ii - prox. Fem. Nail? 9. 0 mm, l 170 mm). This is report 1 of 1 for com - (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612488-2017-10542 |
| MDR Report Key | 6983573 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-10-27 |
| Date of Report | 2017-10-10 |
| Date of Event | 2017-10-10 |
| Date Mfgr Received | 2017-10-10 |
| Device Manufacturer Date | 2017-06-21 |
| Date Added to Maude | 2017-10-27 |
| 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 L90 TAN |
| Generic Name | APPLIANCE,FIXATION,NAIL/BLADE/ PLATE COMBO, SINGLE COMPONENT |
| Product Code | KTW |
| Date Received | 2017-10-27 |
| Catalog Number | 04.027.053S |
| Lot Number | L459694 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 0 | 2017-10-27 |