MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PFNA BLADE PERF L95 SST; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 02.027.034S

Device Problem Disassembly (1168)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: no patient involvement reported.Date of event is unknown.Device malfunction noted pre-operative.No patient was involved.Date of implant/explant are not applicable.Device is not distributed in the united states, but is similar to device marketed in the usa.The device was received and the product evaluation is in progress.No conclusion can be drawn.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 the removal of the pfna blade from the impactor was difficult.It was only possible to remove with increased efforts.This was detected inhouse at the education department.No patient involvement reported.This report is for one (1) pfna blade.(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.Dhr review was completed.Part number: 02.027.034s.Synthes lot number: l829240.Release to warehouse date: 04.April 2018, expiry date: 01.March 2028.Manufacturing site: bettlach.A dhr review was performed for the affected work order, lot l829240 (blade finish good product) and its components: lot l777923 (blade), lot l760191 (sleeve), lot l752506 (endcap) and lot l786498 (screw).During the step 80 (externe produktion steril), 3 parts were detected as not in compliance with the specifications by the supplier and later were scrapped under the code: ¿functional failure¿.As these parts were scrapped, this could not lead to the complaint condition.No further deviations were detected.Customer quality conducted an investigation of the returned device.The returned pfna blade was forwarded to the manufacturing plant for evaluation.The statement below is a summary of their investigation.The received condition of the complaint does not agree with the complaint description since the blade could be locked and unlocked and the blade was tested with the impactor (03.010.410) and was easily assembled and disassembled.From the manufacturing point of view this complaint is rated as not confirmed since no manufacturing issue was detected in the components manufactured in bettlach as well as during this investigation all relevant measurements performed are according to the specifications.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 L95 SST
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7577842
• MDR Text Key: 110348028
• Report Number: 8030965-2018-54177
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819419889
• UDI-Public: (01)07611819419889
• 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: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.027.034S
• Device Lot Number: L829240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2018
• Date Manufacturer Received: 06/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1