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

Model Number 311.01

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a sales representative.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 Description

It was reported on august 07, 2020, during an inspection, it was noticed that one (1) depth gauge had a slight crack coming down the side of the handle, one (1) handle for torque limiting attachment lock had issues locking and unlocking and there was also a click sound when you unlock, and one (1) handle with mini quick coupling no longer locks torque limiter into place.There was no patient involvement.Concomitant device reported: unknown torque limiter (part#: unknown, lot#: unknown, quantity: 1).This report is for one (1) handle with mini quick coupling.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H3, h6: a product investigation was conducted.Visual inspection: the handle with mini quick coupling (p/n: 311.01, lot #: 5710897) was returned and received at us cq.Upon visual inspection, no visual defects were identified with the returned device.Functional test: the functional test cannot be performed on the returned device as the quick coupling was received by itself.However, it was observed that the locking mechanism on the device was not smooth or non-binding.The reported device interaction issue may be caused due to this locking mechanism malfunction.Thus, the overall complaint was confirmed.Service and repair evaluation: it was reported on august 07, 2020, during an inspection, it was noticed that one (1) handle with mini quick coupling no longer locks torque limiter into place.The repair technician reported the supplier is unable to repair the device.Supplier unable to repair 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.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Furthermore, the complaint relevant dimensions cannot be checked for dimensional accuracy, because of the design of the device.Document/specification review: the relevant drawings reflecting current and manufactured revisions were reviewed: based on the review of the above drawings, no design issues contributing to relevant complaint condition were identified.Conclusion: the complaint was confirmed for the received device.There is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the reported condition was caused due to the device's use over 12 years in the field.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.H4, h6: a device history record (dhr) review was conducted: part number:311.01, synthes lot number: 5710897, supplier lot number: n/a, release to warehouse date: 14feb2008, expiration date: n/a, manufactured by synthes brandywine.No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, 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 Description

Corrected event description: it was reported on (b)(6) 2020, during an inspection, it was noticed that one (1) depth gauge had a slight crack coming down the side of the handle, one (1) handle with mini quick coupling had issues locking and unlocking and there was also a click sound when you unlock, and 1) handle for torque limiting attachment lock no longer locks torque limiter into place.There was no patient involvement.

• Brand Name: HANDLE WITH MINI QUICK COUPLING
• Type of Device: TAP,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10480137
• MDR Text Key: 205646351
• Report Number: 2939274-2020-03925
• Device Sequence Number: 1
• Product Code: HWX
• UDI-Device Identifier: 10886982187192
• UDI-Public: (01)10886982187192
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/07/2020

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
• Device Operator: Health Professional
• Device Model Number: 311.01
• Device Catalogue Number: 311.01
• Device Lot Number: 5710897
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2020
• Initial Date Manufacturer Received: 08/07/2020
• Initial Date FDA Received: 09/01/2020
• Supplement Dates Manufacturer Received: 09/08/2020
• Supplement Dates FDA Received: 10/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK - TORQUE DEVICES