MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC AIMING ARM FOR TI CANNULATED TIBIAL NAILS-EX; GUIDE

Catalog Number	03.010.052
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no known reported patient involvement associated with the complained event.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date the aiming device holes are misaligned to the nails holes.It looks like the aiming arm device is offset.There was no patient involvement this report is for one (1) aiming arm for ti cannulated tibial nails-ex.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
Lot number was updated.A review of the device history records has been requested.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.
Additional Manufacturer Narrative
Device history lot, part number: 03.010.052, synthes lot number: 3115151, supplier lot number: 3115151, release to warehouse date: 29-apr-2009, supplier: (b)(4).No ncrs were generated during production.This non-conformance is not relevant to the complaint condition, as it is related to product packaging/part protruding from packaging.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.A visual inspection revealed worn and scratched surfaces on the connecting tabs for insertion handle of the returned aiming arm.No new issues were identified on the remaining portions of the device.With the damage identified the returned device is consistent with the given complaint condition and therefore the overall complaint condition was confirmed.Dimensional analysis was not performed on the features with surface wear as it was noted to be significant post manufacture damage.However further dimensional analysis was performed on all available slots on the device that accepts mating instruments for construct alignment.Dhr review performed showed no issues relevant to complaint condition except for an nc related to packaging which is irrelevant to compliant condition.While no root cause could be determined it is possible that the any unintended improper alignment could have contributed to given complaint condition.Also, it is possible that the observed worn and scratched surfaces on the connecting tab portions would have also led to alignment issues as described in complaint condition.However, the observed worn condition is consistent with device usage for over 9 years.Furthermore, during the investigation no design/manufacturing issues were identified.Therefore, 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.
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.
Event or Problem Description
Concomitant device reported: unknown nail (part # unknown, lot # unknown, quantity 1).
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.H11 corrected data: h4.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: AIMING ARM FOR TI CANNULATED TIBIAL 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: 7951735
• Report Number: 2939274-2018-54284
• Device Sequence Number: 1303217
• Product Code: FZX
• UDI-Device Identifier: 10886982067241
• UDI-Public: (01)10886982067241
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/24/2018

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: 03.010.052
• Device Lot Number: 3115151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2018
• Initial Date Received by Manufacturer: 09/24/2018
• Supplement Date Received by Manufacturer: 10/18/2018; 11/14/2018; 11/28/2018; 12/04/2018
• Initial Report FDA Received Date: 10/10/2018
• Supplement Report FDA Received Date: 11/05/2018; 11/15/2018; 11/28/2018; 12/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1