MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.0NM TORQUE LIMITING HANDLE WITH 4.5MM QUICK COUPLING; MISC ORTHO SURGICAL INSTR

Model Number	03.632.204
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: investigation flow: power tools/calibration.Visual inspection: the 3.0nm torque limiting handle with 4.5 mm quick coupling (p/n: 03.632.204, lot #: 9852480-14) was returned and received at us cq.Upon visual inspection, there were scratches and slight discoloration on the returned device but have no impact on the functionality of the device.No other issues were identified with the returned device.Functional test: the functional test was performed on the returned device at service and repair the highest torque of the device measured during calibration testing was 3.72 nm which was not within the specified torque range of the device of 3 nm - 3.6 nm.Hence, the torque test failed high.Service & repair evaluation: the customer reported the device failed calibration.The repair technician reported the device failed high.Torque test high is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item will be forwarded to customer quality.The evaluation was confirmed.Document/specification review: based on the date of manufacture drawings are reflecting the current and manufactured revision were reviewed.Complaint confirmed? yes, the device received failed in calibration testing.Hence, confirming the allegation.Investigation conclusion: the complaint condition is confirmed as the 3.0nm torque limiting handle with 4.5 mm quick coupling (p/n: 03.632.204, lot #: 9852480-14) failed high in calibration test.There is no indication that a design or manufacturing issue has caused the breakage 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 # 03.632.204.Synthes lot # 9852480-14.Supplier lot # 9852480-14.Release to warehouse date: aug 07, 2015.Supplier: (b)(4).No ncr's 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.
Event or Problem Description
It was reported that on (b)(6) 2020, during inspection, a torque limiting handle with 4.5mm quick coupling failed in calibration.There was no patient involvement.This complaint involves one (1) device.This is 1 of 1 for report (b)(4).

• Brand Name: 3.0NM TORQUE LIMITING HANDLE WITH 4.5MM QUICK COUPLING
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9856136
• Report Number: 2939274-2020-01376
• Device Sequence Number: 3153927
• Product Code: LXH
• UDI-Device Identifier: 10705034719535
• UDI-Public: (01)10705034719535
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 03.632.204
• Device Catalogue Number: 03.632.204
• Device Lot Number: 9852480-14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2020
• Initial Report FDA Received Date: 03/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1