MAUDE Adverse Event Report: SYNTHES BETTLACH PFNA BLADE PERF L100 TAN; APPLIANCE,FIXATION,NAIL/BLADE/ PLATE COMBO, SINGLE COMPONENT

Catalog Number 04.027.035S

Device Problem Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Manufacturer Narrative

Patient information is not available for reporting.(b)(4).Device malfunctioned intra-operatively and was not implanted / explanted.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).Device is not distributed in the united states, but is similar to device marketed in the usa.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.Manufacturing location: (b)(4).Manufacturing date: 29.Aug.2016 expiry date: 01.Aug.2026.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 (b)(4) reports an event in (b)(6) as follows: it is reported the proximal femoral nail antirotate (pfna) blade would not lock during an unknown procedure on unknown date.No surgical delay was reported.Concomitant devices reported: pfna nail (part number unknown, lot number unknown, quantity 1) this report is for one (1) pfna blade this is report 1 of 1 for (b)(4).

• Brand Name: PFNA BLADE PERF L100 TAN
• Type of Device: APPLIANCE,FIXATION,NAIL/BLADE/ PLATE COMBO, SINGLE COMPONENT
• 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: 6578262
• MDR Text Key: 75730507
• Report Number: 9612488-2017-10223
• Device Sequence Number: 1
• Product Code: KTW
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 04/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.027.035S
• Device Lot Number: L105521
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1