MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PFNA BLADE PERF L115 TAN; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.027.038S

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/30/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information is not available for reporting.Due to the intra-operative events, the device was not successfully implanted.As such, implant/explant dates are not applicable.Reporter phone number is not provided for reporting.Device is not distributed in the united states, but is similar to device marketed in the usa.The subject device has been received and the product evaluation is in progress.No conclusion can be drawn.A review of the device history records has been requested and is currently pending completion.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 that during a surgery performed on (b)(6) 2018, surgeon was unable to lock the proximal femoral nail antirotation (pfna) blade.No consequence for the patient reported.Surgery was completed successfully.This report is for one (1) pfna blade perf l115 tan.This is report 1 of 1 for complaint (b)(4).

Event Description

It was further reported that there was forty five (45) minutes of surgical delay.

Manufacturer Narrative

Additional narrative: 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.

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.A device history record (dhr) review was performed for part number: 04.027.038s, synthes lot number: l286867: release to warehouse date: 02.Feb.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.H3, h6: a product investigation was conducted.The investigation has shown that received blade has some scratches and nicks at the shaft.Furthermore, we found that anodized layer is partially disappeared and locking screw is too much inside the blade.Unfortunately, we cannot determine the exact root cause of the complained occurrence as no detailed clinical information was provided.During the investigation it was found, that the locking screw was unable to be screwed back as the hex was found damaged.Because of this damage, neither a functional check nor the complaint relevant dimensions could be checked.Therefore, this complaint is rated as confirmed.We suppose that a mechanical overload situation during use could have led to the damage and finally to the malfunction.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 BLADE PERF L115 TAN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7363683
• MDR Text Key: 103276862
• Report Number: 8030965-2018-52329
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819369528
• UDI-Public: (01)07611819369528(17)270101(10)L286867
• 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,Followup
• Report Date: 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.027.038S
• Device Lot Number: L286867
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2018
• Date Manufacturer Received: 05/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1