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

Model Number 311.44

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/23/2019

Event Type  malfunction  

Manufacturer Narrative

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

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, a t-handle with quick coupling was broken in two (2) pieces during an orthopedic procedure.There were no fragments generated from the broken piece.The procedure was completed using another t-handle.The procedure was successfully completed with no surgical delay.There was no patient consequence.This report is for one (1) t-handle with quick coupling.This is report 1 of 1 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.H3, h4, h6: a device history record (dhr) review was conducted: part # 311.44, synthes lot # 5561105, supplier lot # na, release to warehouse date: 29 aug 2007, manufactured by synthes brandywine.No ncr's 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.H3, h6: a product investigation was conducted.Visual inspection: the t-handle with quick coupling (p/n 311.44 lot 5561105) was returned and received at us cq.A visual inspection was performed.The shaft was broken off from the t-handle.The breakage location of the shaft from the handle occurred at the dowel pin.The shaft was also observed to be slightly bent, off axis.No other issues were identified with the returned components of the device.Device failure/defect was identified.Dimensional inspection: dimensional inspection was conducted and found to be conforming.Investigation conclusion: the complaint was confirmed for the t-handle with quick coupling (p/n 311.44 lot 5561105) as the shaft was broken off from the t-handle at the location of the dowel pin.The shaft was also observed to be slightly bent, off axis.There was 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 conditions were due to overloading (torsional stress) associated with an unintended bending moment or force(s) leading to the breakage.Based on the investigation findings, it was 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
• 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: 8631928
• MDR Text Key: 145774234
• Report Number: 2939274-2019-58201
• Device Sequence Number: 1
• Product Code: HWX
• UDI-Device Identifier: 10886982187413
• UDI-Public: (01)10886982187413
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 311.44
• Device Catalogue Number: 311.44
• Device Lot Number: 5561105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Date Manufacturer Received: 06/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1