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

Catalog Number 02.027.034S

Device Problem Difficult to Remove (1528)

Patient Problem No Patient Involvement (2645)

Event Date 04/27/2018

Event Type  malfunction  

Manufacturer Narrative

There was no known reported patient involvement associated with the complained event.Device is not implanted/explanted.Reporter phone number is not provided for reporting.(510k): 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 the removal of the blade from the blade impactor is difficult and was just with increased effort possible.No patient involvement, issue detected inhouse at the education department.This is report 7 of 13 for complaint (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.Device history record (dhr) review: part number: 02.027.034s; synthes lot number: l809487; release to warehouse date: 22.March 2018; expiry date: 01.March 2028; manufacturing site: bettlach; no nonconformance records (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.Manufacturing investigation summary: the returned pfna - blades were forwarded to the manufacturing side for evaluation.The statement below is a summary of their investigation.From the 12 blades received; 8 were easily locked and unlocked (assembled/disassembled) as described per assembly instructions.One blade was opened/unlocked; however, its components ¿ endcap as the screw were received damaged; this blade could not be tested anymore.Two blades could not be opened/unlocked; these blades could not be tested, as well.Finally, one blade could not be tested due to the blade was cut and its ¿head¿ (part of the end cap) is missing.For the 8 blades, the thread from the screw was measured with a gage (4-19-12206) from bettlach and have passed the specification.In order to perform further analysis regarding to the component end cap (60040596) additional support was requested to depuysynthes balsthal since they have manufactured these components.Therefore, one end cap was cut off in order to be measured from its thread and have passed its specification.In the manufacturing process the function from the end cap ¿funktion endkappe¿ was tested and documented through the inspection sheet.This feature is a product quality plan (pqp) part of the dhr attached.Besides, during the manufacturing process the assembling was performed by the supplier früh in the external production sterile step and there were no issues reported for the lot in question regarding to assembling the blades.In the case when the blades could not be assembled; früh opens a nonconformance (nc) and send back the articles affected to depuy synthes.Regarding to the 8 blades that opened and closed easily, the thread from the screw was measured and have passed its specifications.These blades were also tested with the impactor (03.010.410) and were easily assembled and disassembled.According to the investigation results, this complaint is rated as confirm regarding to 4 blades, which were received damaged and could not be tested.However, since 8 blades were tested with a gage as well as with the instrument ¿impactor¿ (03.010.410) and have passed the functional test, including inspection during manufacturing process these complaint is rated as not valid and any manufacturing issue was excluded.If further analysis regarding to the end cap must be performed, additional investigations must conducted by the depuysynthes balsthal since they have manufactured these components.As this complaint is not valid therefore the review of the specific prm and pra line is not applicable.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: 7516516
• MDR Text Key: 108359841
• Report Number: 8030965-2018-53787
• 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: 04/27/2018

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: 02.027.034S
• Device Lot Number: L809487
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2018
• Date Manufacturer Received: 06/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1