MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HANDLE F/PERCUTANEOUS THREADED DRILL GUIDES; GAUGE,DEPTH

Model Number 03.113.014

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Patient Involvement (2645)

Event Date 09/05/2020

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is jnj representative.The investigation could not be completed, no product was received; 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 during a tibial plateau case on (b)(6) 2020, the unknown aiming arm and the 1.6 mm threaded wire guide was fused together with the handle for drill sleeves and could not be able to get those pieces apart which each other.The issue caused a small delay to the procedure.Another device was used on the case.Patient status and surgical outcomes was successful.This complaint involves three (3) devices.This report is for (1) handle f/percutaneous threaded drill guides.This is report 2 of 3 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, h6: part: 03.113.014, lot: 8581991, manufacturing site: haegendorf, release to warehouse date: december 09, 2013.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the handle f/percutaneous threaded drill guides and 1.6mm percutaneous threaded wire guide were received assembled at customer quality (cq).Both devices were found stuck/ locked, it was not able to disassemble/separate mating device.Hence, the complaint is confirmed.Functional testing: multiple attempts were tried to separate the both the devices.But, they were not able to be separated.Dimensional inspection: a dimensional inspection was not performed as stuck features were inaccessible without destruction of the device.Document/specification review: adapter mit griff m5 guidehandle m5 kpl 163.5 lcp aiming systems conclusion: the complaint is partially 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) which may led devices to be jammed.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 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 F/PERCUTANEOUS THREADED DRILL GUIDES
• Type of Device: GAUGE,DEPTH
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10600030
• MDR Text Key: 208974233
• Report Number: 2939274-2020-04371
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982072818
• UDI-Public: (01)10886982072818
• 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: 09/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.113.014
• Device Catalogue Number: 03.113.014
• Device Lot Number: 8581991
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Date Manufacturer Received: 10/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1.6MM PERCUTANEOUS THREADED WIRE GUIDE; UNK - GUIDES/SLEEVES/AIMING: GUIDE