MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 3.0NM TORQUE LIMITING HANDLE WITH 4.5MM QUICK COUPLING; MISC ORTHO SURGICAL INSTR

Catalog Number	03.632.204
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is a j&j employee.Investigation summary: investigation flow: functional (will not tension/ tighten) visual inspection; torque-limiting handle 3nm (part.No: 03.632.204, lot.No: 6395603-15, qty: 1) was returned and received at us cq.The device shows normal wear without any damage.Functional test: functional test was performed on the returned device at (b)(6).The highest torque of the device measured during calibration testing was 3.64 nm which was not within the specified torque range of the device of 3.1 nm - 3.5 nm as per the 10324757 rev.7.Hence, the torque test failed high.Refer to the attached test report.Can the complaint be replicated with the returned device? yes.Dimensional inspection: dimensional inspection of the torque limiting handle cannot be performed as the internal components of the device were inaccessible.Document/specification review: the following drawings were reviewed: torque limiting handle 4.5 ao quick coupling, 3.0nm for matrix lateral connector: 03_632_204 rev.B and rev.G.Synthes loaner set product specific inspection and verification instructions: 103243757 rev.7.No design issues or discrepancies were noticed.Complaint confirmed? no.Investigation conclusion the complaint condition was confirmed for the torque-limiting handle 3nm (part.No: 03.632.204, lot.No: 6395603-15).A definitive root cause cannot be determined for the complaint condition.Failed torque might be the possible root cause for the complaint condition.During the investigation, no product design issues, or discrepancies were observed that may have contributed to the complaint condition.Based upon these results, 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.Therefore, it has been determined that no corrective and/or preventive action is proposed.Device history lot: part #: 03.632.204, synthes lot number: 6395603-15, supplier lot #: 6395603-15, release to warehouse date: 14-jul-2010, supplier: (b)(4).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
It was reported on (b)(6) 2020 that on an unknown date there was an issue when doing the final tightening of the cross-link system.The torque did not click and thus damaged the cross-link screw.There was no patient consequence.There was no surgical impact.This report is for one (1) 3.0nm torque limiting handle with 4.5mm quick coupling.This is report 1 of 2 for (b)(4).

• Brand Name: 3.0NM TORQUE LIMITING HANDLE WITH 4.5MM QUICK COUPLING
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10551337
• Report Number: 8030965-2020-07176
• Device Sequence Number: 16980404
• Product Code: LXH
• UDI-Device Identifier: 07611819377479
• UDI-Public: (01)07611819377479
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/11/2020

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: 03.632.204
• Device Lot Number: 6395603-15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/11/2020
• Initial Report FDA Received Date: 09/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1