MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC T-HANDLE WITH QUICK COUPLING; TAP, BONE

Model Number	311.44
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on an unknown date, the two (2) reduction forcep points rachet, protection sleeve, trocar, sharp hook, insertion guide, two (2) t-handle with quick coupling, screwdriver shaft, driving cap and radiolucent insertion handle were found damaged after use in surgery.There was no patient consequence reported.This report involves one (1) t-handle with quick coupling.This is report 5 of 8 for (b)(4).
Additional Manufacturer Narrative
Additional narrative: initial reporter is a j&j employee.Part # 311.44, synthes lot # 5634614, supplier lot # na, release to warehouse date: september 11, 2007, manufactured by: synthes (b)(4).No ncrs were 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.The product was returned to us customer quality (cq) for evaluation.The us cq team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the t-handle with quick coupling had a bent shaft and was returned seized with the mating screwdriver shaft.No other issues were identified.The dimensional inspection was not performed due to the post manufacturing damage.The observed condition of the t-handle with quick coupling was consistent with a random component failure that may have been caused by exposure to excessive/unintended forces.A functional test could not be performed as the devices were seized and could not be disassembled.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for the t-handle with quick coupling.While no definitive root cause could be determined from the available information, it is probable that the t-handle with quick coupling was bent and seized due to the exposure to excessive/unintended forces.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 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.

• Brand Name: T-HANDLE WITH QUICK COUPLING
• Common Device Name: TAP, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14345635
• Report Number: 2939274-2022-01696
• Device Sequence Number: 11936513
• Product Code: HWX
• UDI-Device Identifier: 10886982187413
• UDI-Public: (01)10886982187413
• Combination Product (Y/N): N
• 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: 311.44
• Device Catalogue Number: 311.44
• Device Lot Number: 5634614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2022
• Initial Report FDA Received Date: 05/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2007
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DRIVING CAP F/INSERTION HANDLE; DRIVING CAP/THREADED; INSERTION GUIDE; PROTECT SLEEVE 12/8 L188; RADIOLUCENT INSERTION HANDLE FRN; REDUCTION FORCEPS POINTS RATCHET 13; REDUCTION FORCEPS POINTS RATCHET 174; SDDRIVE SCREWDRIVER SHAFT QC/T15; SHARP HOOK; T-HANDLE WITH QUICK COUPLING; TROCAR Ø4.2 F/03.010.065
• Patient Sex: Unknown