MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PERCUTANEOUS INSERTION HANDLE; MISC ORTHO SURGICAL INSTRUMENT

Catalog Number 03.010.046

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 04/12/2018

Event Type  malfunction  

Manufacturer Narrative

Device used for treatment, not diagnosis.Patient information not available for reporting.Device is an instrument and is not implanted/explanted.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Device history records review not available to report at this time.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 tibia nail procedure on (b)(6) 2018 while putting together the percutaneous insertion handle and aiming arm together it was found that the percutaneous insertion handle has a hole that is oblong and would not allow the aiming arm to be inserted.Another set was readily available.While using the insertion handle with the driving cap the threaded part of the driving cap broke off into the insertion handle.There were additional instruments available to complete the surgery.The patient¿s outcome was good.There was a delay in surgery but it is unknown the length of time.There was no medical intervention, unanticipated x-rays and no fragments generated.Surgery was completed successfully.This complaint involves one 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.A device history record (dhr) review was performed for part: 03.010.046, lot: 9921112: manufacturing site: haegendorf, release to warehouse date: 28.June 2016: no non-conformance reports (ncrs) were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.A product investigation was conducted.The percutaneous insertion handle (03.010.046) is routinely used during the insertion of femoral and tibial nails including those in the titanium cannulated retrograde/antegrade femoral nail system and the suprapatellar instrumentation for titanium cannulated tibial nails system among others.The returned insertion handle was examined and the complaint condition was unable to be confirmed as no defects or deficiencies were identified which may have contributed to the complaint condition.The aiming arm in question was not returned, as such the complaint condition was unable to be replicated.Relevant drawings for the returned device were reviewed.The design, materials and finishing processes were found to be appropriate for the intended use of this device.No dimensional analysis is applicable as no defects or deficiencies were identified.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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

Concomitant devices reported: unknown guides/sleeves/aiming: percutaneous (part # unknown, lot # unknown, quantity 1); insert-handle f/etn f/suprapatellar appr (part # 03.010.440, lot # 11-3169, quantity 1).

• Brand Name: PERCUTANEOUS INSERTION HANDLE
• 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: 7488820
• MDR Text Key: 107497709
• Report Number: 2939274-2018-52038
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10886982067180
• UDI-Public: (01)10886982067180
• 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: 04/12/2018

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 Catalogue Number: 03.010.046
• Device Lot Number: 9921112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2018
• Initial Date Manufacturer Received: 04/12/2018
• Initial Date FDA Received: 05/04/2018
• Supplement Dates Manufacturer Received: 05/10/2018
• Supplement Dates FDA Received: 05/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1