MAUDE Adverse Event Report: SYNTHES BRANDYWINE INSERTION HANDLE F/TROCHANTERIC FIXATION NAILS; GUIDE

Catalog Number	357.411
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient weight is unknown.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 device history record review was performed for the subject device lot number 4831470.Manufacturing location: (b)(4).Date of manufacture: 11-apr-2005.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.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 the distal targeting for a 5mm x 36mm locking screw missed the nail during a trochanteric fixation nail (tfn) procedure on (b)(6) 2017 due to issue with getting right trajectory using insertion handle and aiming arm.There was no allegation against locking screw and nail.The surgeon made a second attempt and free-handed the drill bit and was able to get the right trajectory using insertion handle and aiming arm to get the screw in.There was a reported ten minute surgical delay from the second attempt to get construct lined up correctly.No additional x-rays or other medical intervention required.The procedure was completed successfully with the patient in stable condition.Concomitant devices reported: 5.0mm ti locking screw 36mm- for im nails (part # 458.936, lot # unknown, quantity # 1), 4.0mm three-fluted drill bit qc/260mm/65mm calibration (part # 357.407, lot # unknown, quantity # 1), 10mm short trochanteric fixation nail (10x170mm) (part # unknown, lot # unknown, quantity # 1).This is report 2 of 2 for (b)(4).
Additional Manufacturer Narrative
A product development investigation was performed.This complaint was not able to be confirmed or replicated at customer quality (cq).A visual inspection under 5x magnification, functional test, device history record (dhr) review and drawing review were performed as part of this investigation.The returned insertion handle and aiming arm were assembled with known good mating parts at cq in attempt to replicate the complaint condition of distal locking screw misalignment.The following devices were used to complete the construct for this complaint related to distal locking.The returned insertion handle and aiming arm assembled with known good devices at cq resulting in successful alignment with respect to distal locking.10mm/130 deg ti cann troch nail, part#456.315, lot#6700338.Cannulated connecting screw, part#357.397, lot#6606047.Ball hex screwdriver 8mm, part#357.515, lot#4936924.11.0mm/8.0mm protection sleeve, part#357.386, lot#4575038.8.0mm/4.0mm drill sleeve 164m, part#357.389, lot#4582001.4.0mm trocar 176mm, part#357.387, lot#4588829.No new malfunctions were identified as a result of the investigation.The returned devices are reusable instruments in the trochanteric fixation nail (tfn) system.Aiming arm for trochanteric fixation nails (part#357.366) and insertion handle (part#357.411) show minor wear and scratches consistent with field use.No damage that would impair function was observed.Relevant drawings were reviewed during this investigation.No product design issues or discrepancies were observed.Unable to determine a definitive root cause as this complaint is unconfirmed.No new, unique or different patient harms were identified as a result of this evaluation.The returned parts were determined to be suitable for the intended use when employed and maintained as recommended.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: INSERTION HANDLE F/TROCHANTERIC FIXATION NAILS
• Common Device Name: GUIDE
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• MDR Report Key: 6710469
• Report Number: 2530088-2017-10222
• Device Sequence Number: 16521185
• Product Code: FZX
• UDI-Device Identifier: 10886982196347
• UDI-Public: (01)10886982196347(10)4831470
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2017

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: Other Health Care Professional
• Device Catalogue Number: 357.411
• Device Lot Number: 4831470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2017
• Initial Date Received by Manufacturer: 06/18/2017
• Supplement Date Received by Manufacturer: 07/26/2017
• Initial Report FDA Received Date: 07/13/2017
• Supplement Report FDA Received Date: 07/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR