MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH PFNA BLADE PERF L100 SST; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 02.027.035S

Device Problems Positioning Failure (1158); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Patient information is unknown.It is unknown when the event occurred.510k: this report is for a blade - unknown lot.Device is not distributed in the united states, but is similar to device marketed in the usa.Complainant part has not been returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.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.

Event Description

It was reported that intraoperatively it was not possible to lock the proximal femoral blades.This complaint involves 2 parts.This is report 1 of 2 for (b)(4).This report is for one (1) blade.

Manufacturer Narrative

A device history record review was performed for the subject device part number: 02.027.035s, synthes lot number: l569648.Release to warehouse date: 15 sep 2017, expiry date: 01.Sep 2027.Manufacturing site: (b)(4).No 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 development investigation was performed for the subject device: the returned pfna blade was examined and the complaint condition was able to be confirmed.The investigation has shown that the locking screw is too deep inside the blade and therefore the blade could not be locked.In addition, the hexagonal recess of the locking screw is severely damaged, it is clearly visible that the impactor was not positioned properly (see pictures attached).The sleeve of the blade shows normal signs of use.During the investigation the locking screw was screwed back into position with a standard hex-wrench and afterwards the device was fully functional again.Despite the existing damage, the blade could be locked and unlocked as required with an impactor 356.823 (sample).The review of the device history record revealed that this implant was manufactured in september 2017.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements with no non-conformities noted; visual and functional checked were performed per 100% after the assembly of the component parts.No manufacturing related issues that would have contributed to this complaint were found; this complaint condition is most likely due to inadequate handling.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 L100 SST
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF : SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7188048
• MDR Text Key: 97581500
• Report Number: 8030965-2018-50329
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.027.035S
• Device Lot Number: L569648
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1