MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PFNA-II BLADE L85 TAN; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.027.052S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Patient information not available for reporting.Device malfunctioned intra-operatively and was not implanted / explanted.Initial reporter telephone not available for reporting.Device is not distributed in the united states, but is similar to device marketed in the usa.A review of the device history records has been requested.Subject device has been received and is currently in the evaluation process.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.

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported two (2) separate proximal femoral nail antirotation (pfna) ii blades do not lock as intended.It is not known if the issue was discovered during a surgical procedure or outside the operating room.This report is for one (1) pfna ii blade 85mm.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional narrative: a device history record (dhr) review was conducted for part number: 04.027.052s, synthes lot number: l267151: release to warehouse date: 19.Jan.2017, expiry date: 01.Jan.2027, manufacturing site: bettlach: no non-conformance reports (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 investigation was conducted.Visual inspection: the complained pfna-ii blade was received in partially unlocked position.The blade could be turned freely.No signs of damage / use could be identified.The device is in good condition.Functional test: the carried out functional test could not reproduce the reported problem.The complained blade could be locked and unlocked as intended (see attached pictures).The blade in question is in faultless condition.There for this complaint is classified as unconfirmed.We recommend considering pfna-ii surgical technique guide; assemble pfna-ii blade on impactor to prevent any problems.No product problem could be identified.The root cause was identified during the performed cq evaluation and therefore the in the investigation flow listed remaining investigation step are not required.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.

• Brand Name: PFNA-II BLADE L85 TAN
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7516068
• MDR Text Key: 108356734
• Report Number: 8030965-2018-53776
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819394216
• UDI-Public: (01)07611819394216
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.027.052S
• Device Lot Number: L267151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Date Manufacturer Received: 06/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1