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	Failure to Align (2522)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Patient age/date of birth and weight are unknown.Device is an instrument and is not implanted/explanted.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
It was reported that during a trochanteric fixation nail (tfn) procedure on (b)(6) 2017, upon inserting the helical blade, the aiming arm was aiming to posterior causing the helical blade to hit the nail.Once the surgeon realized this, he manipulated the helical blade to appropriately insert the nail.The procedure was completed successfully using the same helical blade, without further issues and no time delay.No other information provided.Concomitant device(s) reported: blade guide sleeve (part 357.369, lot unknown, quantity 1); helical blade inserter (part 357.372, lot unknown, quantity 1).This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
A device history record (dhr) review was performed for part#357.366, lot#5633982: manufacturing location: synthes (b)(4), manufacturing date: 05.Nov.2007: no non-conformance reports (ncrs) were generated during production.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.A product investigation was performed.It was reported that during a trochanteric fixation nail (tfn) procedure on (b)(6) 2017, upon inserting the helical blade, the aiming arm was aiming to posterior causing the helical blade to hit the nail.Once the surgeon realized this, he manipulated the helical blade to appropriately insert the nail.The procedure was completed successfully using the same helical blade, without further issues and no time delay.No other information provided.The 357.366 130 deg aiming arm f/trochanteric fixation nails is part of the trochanteric fixation nail system and is used to achieve the proper angle for inserting the helical blade for proximal locking of the nail and a locking bolt/screw for distal locking of short nails.The 130 degree aiming arm is one of three aiming arms available in the system (125 degree - part #357.365 and 135 degree - part #357.367).Visual inspection of the returned aiming arm at customer quality (cq) revealed minor wear marks but nothing that would impair function.A functional test to replicate the reported complaint condition could not be performed because all of the instruments and implants used in the event were not returned.A dimensional inspection was not performed at cq because there is no indication that dimensions suddenly caused the returned 10+ year old reusable instrument to cause a misalignment.Top level drawings were reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.The material and relevant material properties were determined to be conforming at the time of manufacture based on review of the dhr.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Physical manufacturer 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
The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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
Updated concomitant devices: buttress compression nut (part 357.371, lot 5519091, quantity 1); blade guide sleeve (part 357.369, lot 5533183, quantity 1); guide wire (part 357.381, lot 5531162, quantity 1); trocar (part 357.383, lot 5591023, quantity 1); helical blade inserter (part 357.372, lot unknown, quantity 1).

• 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: 7169622
• Report Number: 2939274-2018-50100
• Device Sequence Number: 13909871
• Product Code: FZX
• UDI-Device Identifier: 10886982196019
• UDI-Public: (01)10886982196019(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/07/2017

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: 5633982
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2018
• Initial Date Received by Manufacturer: 12/07/2017
• Supplement Date Received by Manufacturer: 01/19/2018; 01/19/2018
• Initial Report FDA Received Date: 01/05/2018
• Supplement Report FDA Received Date: 01/30/2018; 02/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1