MAUDE Adverse Event Report: SYNTHES GMBH SCREW INSERTER; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 03.037.025

Device Problem Material Deformation (2976)

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

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Reporter is a j&j sales representative.Investigation summary: investigation flow: damage / device interaction / functional.Visual inspection: the tfna screw inserter (part #: 03.037.025, lot #: l142174) was received at us cq.Visual inspection of the complaint device showed no defects with the device.No other issues were identified with the returned device.The complaint can be replicated with the returned device(s).Functional test: a functional assessment was performed on the complaint device with the returned mating device connecscr f/tfna helic blade+scr, part #: 03.037.026, lot #: l181947.The devices showed some resistance while assembling/ disassembling due to the stripped threads of the mating device (part #: 03.037.026) and were not assemble/ disassemble as intended.Dimensional inspection: dimensional inspection was not performed as there was no evidence of damage.Document/specification review: based on the date of manufacture the following drawings, reflecting the current and manufactured revision were reviewed.The complaint was confirmed.Investigation conclusion: this complaint is not confirmed as there were no bent features observed with the device.However, the damaged threads of the mating device caused device interaction issue.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: part: 03.037.025, lot: l142174, manufacturing site: (b)(4), release to warehouse date: dec.07, 2016.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.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 reports an event in (b)(6) as follows: it was reported on an unknown date that the instrument was found bent upon inspection while is in sales call.There was no surgery and patient involvement are reported.This complaint involves two (2) devices.This report is for (1) screw inserter.This report is 1 of 1 (b)(4).

• Brand Name: SCREW INSERTER
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• 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: 11815503
• MDR Text Key: 250771413
• Report Number: 8030965-2021-03885
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819642515
• UDI-Public: (01)07611819642515
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K131548
• 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: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.037.025
• Device Lot Number: L142174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2016
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1