MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TORQUE LIMITER, 0.8 NM, WITH AO/ASIF QUICK COUPLING; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Model Number	511.776
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: initial reporter is j&j company representative.Investigation summary the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the torque limiter, 0.8 nm, with ao/asif quick coupling was found to have segments of brown foreign matter around the slid sleeve section.Functional issues are most likely due to this condition.A dimensional inspection for the torque limiter, 0.8 nm, with ao/asif quick coupling was unable to be performed due to complex geometry of the device.A functional test was performed, force was applied to slide the slid sleeve, but due to foreign matter in the area the device was not able to be used as intended.The complaint condition was able to be replicated.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the torque limiter, 0.8 nm, with ao/asif quick coupling would contribute to the complained device issue.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.Drawing/specifications reviewed: no issues dimensional inspection: n/a device history part #: 511.776 synthes lot #: 5606 supplier lot #: 5606 release to warehouse date: 19 jan 2009 supplier: (b)(4).No ncr's generated during production.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 that on unknown date, in sterile processing department (spd), the nozzle of one (1) torque limiter could not be pulled back.There was no patient involvement.This is report 1 of 1 for (b)(4).This report is for a torque limiter.

• Brand Name: TORQUE LIMITER, 0.8 NM, WITH AO/ASIF QUICK COUPLING
• Common Device Name: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14454540
• Report Number: 2939274-2022-01792
• Device Sequence Number: 6354131
• Product Code: GEY
• UDI-Device Identifier: 10886982237866
• UDI-Public: (01)10886982237866
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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 Model Number: 511.776
• Device Catalogue Number: 511.776
• Device Lot Number: 5606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/04/2022
• Initial Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2009
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown