MAUDE Adverse Event Report: SYNTHES HAGENDORF CANNULATED CONNECTING SCREW; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 03.037.010

Device Problems Failure To Adhere Or Bond (1031); Dull, Blunt (2407)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Manufacturing location: (b)(4).Manufacturing date: september 24, 2015.No non-conformance reports 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.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 during a routine set inspection the threads on the connecting screw were found to be stripped and will not engage properly.There is no case or patient involvement.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.One (1) cannulated connecting screw (part 03.037.010, lot 9518512, mfg 24-sep-2015) was returned with a complaint stating that the threads of the connecting screw were found to be stripped and not engaging the nail properly.A visual inspection and drawing review were performed as part of this investigation.The complaint was able to be confirmed at customer quality as the most distal threads were visibly rolled and damaged.Replication of the complaint is not applicable as the device was visibly deformed.Relevant product drawing was reviewed during the investigation.No drawing issues or discrepancies were noted.The design is adequate for its intended use and did not contribute to this complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The cannulated connecting screw is part of the depuy synthes tfnadvanced (tfna) proximal femoral nailing system.The system is utilized for the intramedullary fixation of proximal femoral fractures.The instrument aids in the insertion of the titanium nail (per technique guide).No definitive root cause was able to be determined.Soft tissue pressure on the insertion handle leads to angle error on the axis between the nail and the insertion handle which inhibit the loosening and removal of the connection screw.This may contribute to thread stripping of the connecting screw.Additionally, off angle insertion and excessive force during insertion or removal may have contributed to the damaged threads of the connecting screw.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CANNULATED CONNECTING SCREW
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5963812
• MDR Text Key: 55159433
• Report Number: 3003875359-2016-10500
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.037.010
• Device Lot Number: 9518512
• Other Device ID Number: (01)10886982070265(10)9518512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2015
• 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