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

Catalog Number 311.43

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Device received.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.A review of the device history record has been requested.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 that on an unknown date, during an unknown procedure, the handle with quick coupling, small broke while the surgeon was putting in screws.It is unknown if there was a surgical delay.The procedure was successfully completed.There was no patient consequences.Concomitant device reported: unk - screws: trauma (part # unknown, lot # unknown, quantity unknown).This complaint involves one (1) device.This report is 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.The handle with quick coupling, small (p/n 311.43 lot 7665450) was received with a portion of the handle broken off, the broken off portion was returned.The transverse fracture was approximately 27.38 mm from the proximal end of the handle.Additionally, there was a vertical crack across the location of the dowel pin and measured approximately 19.32 mm in length.The crack starts at the proximal end of the handle and propagates distally.No other issues were identified with the returned components of the device.The complaint condition is confirmed for the handle with quick coupling, small (p/n 311.43 lot 7665450) as a portion of the handle was broken off.Additionally, there was a vertical crack across the location of the dowel pin.A valid design defect was identified as the root cause of the complaint condition.Capa-005371 was launched to address the design defect and was closed on 02 aug 2017 after effectiveness monitoring of the design changes was deemed effective.No manufacturing issues were identified through the investigation.A corrective and/or preventative action has already been launched and completed to address the design deficiency.See related action.Based upon these findings, no additional 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 history lot part # 311.43, synthes lot # 7665450, supplier lot # na, release to warehouse date: 09 may 2014, manufactured by synthes jennersville, 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.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: HANDLE WITH QUICK COUPLING, SMALL
• 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: 8760397
• MDR Text Key: 150017493
• Report Number: 2939274-2019-59020
• Device Sequence Number: 1
• Product Code: HWX
• UDI-Device Identifier: 10886982187390
• UDI-Public: (01)10886982187390
• 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,health
• Type of Report: Initial,Followup
• Report Date: 06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 311.43
• Device Lot Number: 7665450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2019
• Date Manufacturer Received: 07/10/2019
• Patient Sequence Number: 1