MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC RECON LOCKING AIMING ARM FOR LATERAL ENTRY FEMORAL NAILS-EX; GUIDE

Catalog Number	03.010.048
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was not provided for reporting.Device is an instrument and is not implanted / explanted.Device is expected to be returned for manufacturer review/investigation, but has not been received yet.Reporter is synthes sales representative.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Additionally, device history records review could not be completed without lot number.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 or Problem Description
(b)(6) reported following: it was reported on the unknown procedure on (b)(6) 2018, that the recon locking aiming arm did not align as it should and did not give the right measure.Produce was completed using another device.Patient outcome was not reported.This report is for one (1) recon locking aiming arm for lateral entry femoral nails-ex.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
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 or Problem Description
Further it was clarified that the device being failed to align means it did not give the right measure for the implant to fit.Concomitant device reported: unknown implant (part# unknown, lot# unknown, quantity unknown).
Additional 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 device was received, and the product evaluation is in progress.No conclusion can be drawn.Additionally, device history records review 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.
Additional 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.Complainant part is not expected to be returned for manufacturer review/investigation.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 or Problem Description
There was no surgical delay and no patient consequences.The procedure was completed successfully.
Additional 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.Dhr review: the returned device was manufactured in january 2009 and is over 9 years old.There were no mrrs or ncrs associated with this lot.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Device history : lot 6060692 , part 03.010.048 , released to warehouse 16jan2009, manufactured by synthes brandywine.Synthes brandywine manufactured the recon locking aiming arm for lfn, p/n 03.010.048, and lot number 6060692 for work order 1906189 wb.The parts conformed to all requirements of brandywine inspection sheet, completed 1/15/09.There were no mrrs or ncrs associated with this lot.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Document/specification review: the following design drawings were reviewed during this investigation.The 03.010.048 recon locking aiming arm is a reusable instrument routinely used in the titanium cannulated lateral entry femoral recon nail system.No product design issues or discrepancies were observed during this investigation.Dimensional inspection:/conclusion: a definitive root cause for the reported condition of failing to align could not be determined based on the provided information.This complaint was not able to be confirmed and no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.No new, unique or different patient harms were identified as a result of this evaluation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Investigation flow: device interaction/functional visual inspection: visual inspection of the returned aiming arm performed at customer quality (cq) identified minor superficial surface wear and scratches on the aiming arm body that are through the black hard coat anodize layer revealing the base aluminum substrate but which do not inhibit functionality.No abnormalities or damage that would prevent function were observed.Functional test: as only the aiming arm was returned and no other devices involved in the construct at the time of the event were returned for investigation, the reported complaint condition was not able to be replicated or confirmed.Device was used for treatment, not diagnosis.
Additional 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.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: RECON LOCKING AIMING ARM FOR LATERAL ENTRY FEMORAL NAILS-EX
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7803022
• Report Number: 2939274-2018-53424
• Device Sequence Number: 1909177
• Product Code: FZX
• UDI-Device Identifier: 10886982067203
• UDI-Public: (01)10886982067203
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 08/02/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 03.010.048
• Device Lot Number: 6060692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2018
• Initial Date Received by Manufacturer: 08/02/2018
• Supplement Date Received by Manufacturer: 08/27/2018; 09/25/2018; 11/27/2018; 12/14/2018; 12/19/2018
• Initial Report FDA Received Date: 08/21/2018
• Supplement Report FDA Received Date: 09/21/2018; 10/09/2018; 12/13/2018; 12/17/2018; 12/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1