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 Failure to Align (2522)

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

Event Date 07/16/2017

Event Type  malfunction  

Manufacturer Narrative

Patient id, date of birth/age and weight were not provided for reporting.(b)(4).Device malfunctioned intraoperatively.Device was not implanted/explanted.(b)(6).Device is not distributed in the united states, but is similar to device marketed in the usa.Device history records review was completed for part# 04.027.035s, lot# l296655.Manufacturing location: (b)(4), manufacturing date: feb 10, 2017, expiry date: feb 01, 2027.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Device history records review was completed for: subcomponent # 60039999, lot# l081496.Manufacturing location: (b)(4), manufacturing date: aug 11, 2016.Subcomponent # 60026319, lot# l284415.Manufacturing location: (b)(4), manufacturing date: jan 20, 2017.Subcomponent # 60026321, lot# l275050.Manufacturing location: (b)(4), manufacturing date: jan 12, 2017.Subcomponent # 60026322, lot# l248084.Manufacturing location: (b)(4), manufacturing date: jan 03, 2017.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Product development investigation was completed.A visual inspection and device history records (dhr) review was completed as part of this investigation.This complaint is unconfirmed.Visual inspection showed that the blade was in bad condition.Lot of signs indicated hard mechanical attack during insertion.The in-hex locking screw of the mechanism was screwed in too deep into the sleeve.Nevertheless, we could lock and unlock the mechanism during functional test.Therefore, definitive root cause could not be determined for the reported problem.This complaint is unconfirmed.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 on (b)(6) 2017 during the surgery, head of a pfna blade did not lock properly after insertion.The surgeon used another blade which worked well.There was a prolongation of 30 to 40 minutes.The surgery was completed successfully with a second blade.Patient outcome was not reported.Concomitant device reported: pfna nail (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: 6787870
• MDR Text Key: 83144253
• Report Number: 9612488-2017-10400
• Device Sequence Number: 1
• Product Code: KTW
• Combination Product (y/n): N
• Reporter Country Code: EN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 04.027.035S
• Device Lot Number: L296655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1