MAUDE Adverse Event Report: SYNTHES HAGENDORF 130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS; GUIDE

Catalog Number	357.366
Medical Device Problem Codes	Failure to Align (2522); Unintended Movement (3026)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.No patient involvement reported.Implant and explant dates: device is an instrument and is not implanted/explanted.Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Device history records review was conducted.The report indicates that the: part 357.366, lot 8391294.Manufacturing location: (b)(4).Manufacturing date: 12.Jul.2013.No 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.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 buttress/compression nut would not seat properly, blade guide sleeve for trochanteric fixation nails was not seating properly, 130 deg aiming arm for trochanteric fixation nails would not align, and recon locking aiming arm for lateral entry femoral nails-ex was bent this was discovered during inspection in the sterile processing department.This complaint is for one devices this report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Product development investigation was completed.The investigation summary indicates that: part 357.366; lot 8391294 it was reported that the buttress/compression nut would not seat properly, blade guide sleeve for trochanteric fixation nails was not seating properly, 130 deg aiming arm for trochanteric fixation nails would not align, and recon locking aiming arm for lateral entry femoral nails-ex was bent this was discovered during inspection in the sterile processing department.Customer quality (cq) engineering investigation: this complaint is confirmed.A functional test at cq (assembly of the returned buttress compression nut with returned blade guide sleeve and 357.366 aiming arm) revealed a loose connection which could contribute to misalignment.The loose connection / toggle is due to the 357.366 aiming arm which has post manufacturing damage in the form of 4 loose pins that hold the gold cap in place.The blade guide sleeve and buttress nut will not stay secure when locked to the aiming arm because the aiming arm locking slide plate is loose due to the loose gold cap and pins.A visual inspection under 5x magnification, device history record (dhr) review and drawing review were performed at cq for the returned devices as part of this investigation.The aiming arm shows cumulative wear/post manufacturing damage in the form of scratches, nicks and dents and all 4 helical knurl pins that secure the gold cap are loose.The material and relevant material properties were determined to be conforming at the time of manufacture based on review of the dhrs.No product design issues or discrepancies were observed.Dimensional inspection was not performed as the gold cap was visually confirmed to be loose due to post manufacturing damage (4 pins that secure the gold cap are backing out / loose).The complaint condition was able to be replicated at cq.No new malfunctions were identified as a result of the investigation.No new, unique or different patient harms were identified as a result of this evaluation.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.Device 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): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• MDR Report Key: 7011886
• Report Number: 3003875359-2017-10552
• Device Sequence Number: 1851782
• Product Code: FZX
• UDI-Device Identifier: 10886982196019
• UDI-Public: (01)10886982196019(10)8391294
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 10/16/2017

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: 8391294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2017
• Initial Date Received by Manufacturer: 10/16/2017
• Supplement Date Received by Manufacturer: 12/06/2017
• Initial Report FDA Received Date: 11/08/2017
• Supplement Report FDA Received Date: 12/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1