MAUDE Adverse Event Report: SYNTHES GMBH GUIDE WIRE 3.2MM FOR PFNA BLADE; EXTRACTOR

Catalog Number 356.830

Device Problems Break (1069); No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 (b)(6) reports an event as follows: it was reported that on an unknown date that the 40cm long pin used for the implantation of the proximal femoral nail antirotation (pfna) was broken.Concomitant device: unknown proximal femoral nail (pfna) (part# unknown, lot# unknown, quantity 1).This report is for one (1) guide wire 2.8mm length 460mm with hook.This is report 1 of 1 for (b)(4).

• Brand Name: GUIDE WIRE 3.2MM FOR PFNA BLADE
• Type of Device: EXTRACTOR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11974620
• MDR Text Key: 255378042
• Report Number: 8030965-2021-04759
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 07611819267985
• UDI-Public: 07611819267985
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• 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,Followup
• Report Date: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 356.830
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/03/2021
• Initial Date FDA Received: 06/10/2021
• Supplement Dates Manufacturer Received: 06/09/2021
• Supplement Dates FDA Received: 06/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - NAILS: PFNA