MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HANDLE FOR TORQUE LIMITING ATTACHMENT; MISC, ORTHO, SURGICAL, INSTRUMENT

Model Number 03.110.005

Device Problem Device Difficult to Maintain (3134)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Product complaint #
=
> (b)(4).A review of the device history record has been requested.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.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 routine incoming inspection of a loaner set, it was observed that the latch of the handle for torque limiting attachment would not hold the mating part.There was no patient involvement.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.Flow: functional.Visual inspection: upon visual inspection, there was no breakage was found on the device.The press button was found to be stuck/jammed.Functional testing: the functional testing could not be performed as mating device was not received for investigation.However, the press button was found to be stuck/jammed.It is possible that the stuck button can contribute to the reported condition.Dimension inspection: inner diameter at distal end was measured as 5.5 mm (used gp32) which is with in specification of 5.5 +0.10/0.05 mm per se_081635 rev g.Document/specification review: se_081635 rev g.Se_081645 rev m & n.Se_081641 rev i.Complaint confirmed: yes.Conclusion: the complaint is confirmed.A definitive root cause could be determined it is possible that the device encountered unintended forces (during usage or handling at the time of surgery).During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.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 history lot: part: 03.110.005.Lot: 2746999.Manufacturing site: bettlach.Release to warehouse date: june 14, 2011.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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 FOR TORQUE LIMITING ATTACHMENT
• Type of Device: MISC, ORTHO, SURGICAL, INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9258573
• MDR Text Key: 191031215
• Report Number: 2939274-2019-61847
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10886982071835
• UDI-Public: (01)10886982071835
• 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: 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.110.005
• Device Catalogue Number: 03.110.005
• Device Lot Number: 2746999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2019
• Date Manufacturer Received: 11/21/2019
• Patient Sequence Number: 1