MAUDE Adverse Event Report: SYNTHES BETTLACH PFNA BLADE PERF L105 SST; APPLIANCE,FIXATION,NAIL/BLADE/

Catalog Number 02.027.036S

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 09/11/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).Device is not distributed in the united states, but is similar to device marketed in the usa.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Device history record (dhr): 02.027.036s / l512064.Manufacturing location: (b)(4).Manufacturing date: 09.Aug.2017 expiry date: 01.Aug.2027.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.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 it was not possible to tighten the proximal femoral nail anti-rotation (pfna) blade after the insertion.For the unlocking the key for the blade was used.The blade is still in the hospital for decontamination.Surgery was successfully completed with another pfna blade and a prolongation of 15 minutes.No further surgery is required.Concomitant parts: 1x key for pfna blade, 356.832/ lot unknown; 1x impactor f/pfna blade, 03.010.410 / lot unknown; 1x pfna blade, perforated, l 105mm, 02.027.036s / lot unknown.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Product development investigation was completed.A visual inspection, device history records review and function test were performed as part of this investigation.The returned pfna blade does not show any obvious damage.The inside sleeve is too wide unscrewed as received.The present pfna blade was analyzed for conformance to print specifications as well as the device history record was researched; no abnormal findings were identified.Manufacturing and inspection records indicated no problems with the lot in question.After the inner threaded sleeve (hexagon socket) screwed in original position as mounted, a function test was performed and the device was functional as required.Based on these findings we conclude that the cause of failure is not due to any manufacturing non-conformances.We can only assume that the blade was not correctly connected to the instrument, as the position of the inside sleeve confirmed.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 L105 SST
• Type of Device: APPLIANCE,FIXATION,NAIL/BLADE/
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6900551
• MDR Text Key: 87628905
• Report Number: 9612488-2017-10493
• Device Sequence Number: 1
• Product Code: KTW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.027.036S
• Device Lot Number: L512064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 1 QTY, PART 02.027.036S / LOT UNKNOWN.; 1 QTY, PART 03.010.410 / LOT UNKNOWN,; 1 QTY, PART 356.832/ LOT UNKNOWN,