MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HANDLE WITH MINI QUICK COUPLING, STAINLESS STEEL; TAP,BONE

Model Number	310.95
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device used in a veterinary case - no patient information will be reported.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Received device was manufactured at bettlach manufacturing site on september 27, 2017.The device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and functional criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.Conclusion: while no definitive root cause could be determined, it is possible that consistent use and possible rough handling during surgery or sterile processing could have led to damage to the internal components, which could contribute to the complaint condition of not engage properly.However, the mating device for the handle with mini quick coupling was not returned, therefore the complaint condition cannot be confirmed.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot, part: 310.950, lot: l557528, manufacturing site: (b)(4), release to warehouse date: 27.Sep.2017.The device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and functional criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product 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
Veterinary complaint: it was reported that on an unknown date, during an initial implant to repair a fracture, a handle with mini quick coupling was not locking into the handle.It was noted that it fits on the shaft fine, but the sleeve will not grasp.It was also reported that the screwdriver was not grabbing screws.The procedure was completed successfully with a surgical delay of approximately sixty (60) minutes.There was no impact to the patient.It was further reported that devices were not working appropriately since they have had them.Concomitant device reported: unknown screws (part # unknown, lot # unknown, quantity unknown).This report is for one (1) handle with mini quick coupling, stainless steel.This is report 2 of 2 for (b)(4).

• Brand Name: HANDLE WITH MINI QUICK COUPLING, STAINLESS STEEL
• Common Device Name: TAP,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8545418
• Report Number: 2939274-2019-57618
• Device Sequence Number: 19447300
• Product Code: HWX
• UDI-Device Identifier: 10886982187147
• UDI-Public: (01)10886982187147
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 04/18/2019

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: 310.95
• Device Catalogue Number: 310.95
• Device Lot Number: L557528
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2019
• Initial Report FDA Received Date: 04/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1