MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS; GUIDE

Catalog Number	357.366
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.A review of the device history records 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.
Event or Problem Description
It was reported that during the open reduction internal fixation (orif) prophylactic cephalomedullary nail procedure on (b)(6) 2018, four (4) rivets around the gold band on aiming arm f/trochanteric fixation nails broke causing the aiming arm locking device to fall on the floor.Both the locking device and gold band were flashed, and surgery was resumed without incident.There was a ten (10) minute delay for flash sterilization.Patient outcome was not reported.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
A device history record (dhr) review was conducted.Part number: 357.366, synthes lot number: 4438937, supplier lot number: n/a, release to warehouse date: (b)(6) 2002, expiration date: n/a.Manufactured by (b)(4).The raw material was confirmed to be correct per the specification with no (relevant) non-conformance noted.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 this product, and any subcomponents, which would contribute to this complaint condition.A product investigation was conducted.The instrument was received with the reported condition of ¿broken (2+ pieces) intraoperatively: rm¿ the following investigation flow was performed: visual (appearance not as expected): the returned instrument was examined and there was no evidence the device had any broken components, instead it was visually seen that 3 of the 4 2.5mm down pins was found to be missing; resulting in the complaint condition.In addition, the compression spring may be missing or pushed so far back in as when functionally tested there was no resistance when depressing the locking slide plate.The balance of the device is in fair condition.The reported malfunction of ¿broken¿ was not observed and therefore does not agree complaint description.Relevant drawings for the returned device were reviewed (both current and from the time of manufacture): top was reviewed and no issues were detected.Dimensional inspection was performed per relevant drawing: diameter of dowel pin holes were measured and is conforming.A root cause could not be determined as the circumstances surrounding the complaint are unknown; the condition was likely impacted by over 15.5 years of use in the filed resulting in loosening of the pins which eventually fell out and lead to the observed complaint condition.During the investigation, no product design or manufacturing issues 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.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: 130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7865038
• Report Number: 2939274-2018-53731
• Device Sequence Number: 16647401
• Product Code: FZX
• UDI-Device Identifier: 10886982196019
• UDI-Public: (01)10886982196019
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2018

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: 357.366
• Device Lot Number: 4438937
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2018
• Initial Date Received by Manufacturer: 08/23/2018
• Supplement Date Received by Manufacturer: 10/15/2018
• Initial Report FDA Received Date: 09/11/2018
• Supplement Report FDA Received Date: 10/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1