MAUDE Adverse Event Report: SYNTHES GMBH 2NM TORQUE LIMITING HANDLE WITH QUICK COUPLING; SCREWDRIVER

Catalog Number	389.471
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is a j&j sales representative.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.Visual inspection: the handle 2nm (p/n: 389.471, lot #: 6985983-01) was returned and received at us cq.Upon visual inspection, there were scratches on the device but have no impact on the device functionality.No other issues were observed with the returned device.Functional test: torque test were performed at third party logistics facility.The torque was measured to be 2.5 nm.This is not within the specification of 1.7 nm - 2.1 nm, per 389_471 rev.N.Document/specification review based on the date of manufacture, the current and manufactured revision of drawings were reviewed torque limiting handle, quick coupling: 389_471 rev.T/n investigation conclusion: the complaint condition was confirmed for the returned device.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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 # 389.471 synthes lot # 6985983-01 supplier lot # 6985983-01 release to warehouse date: 29aug2012 supplier: (b)(4) no ncrs were generated during production.Device history review - review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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 or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that, during a loan set inspection at a third party logistics facility instrument torque test was failed with a reading of 2.6 nm & 2.5 nm respectively.This report is for one (1) 2nm torque limiting handle with quick coupling.This is report 2 of 2 for complaint (b)(4).

• Brand Name: 2NM TORQUE LIMITING HANDLE WITH QUICK COUPLING
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12442811
• Report Number: 8030965-2021-07579
• Device Sequence Number: 17128508
• Product Code: HXX
• UDI-Device Identifier: 07611819753044
• UDI-Public: (01)07611819753044
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/11/2021

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
• Operator of Device: Health Professional
• Device Catalogue Number: 389.471
• Device Lot Number: 6985983-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2021
• Initial Report FDA Received Date: 09/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1