MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM/130 DEG TI CANN TFNA 380MM/RIGHT - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.037.058S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been received and the product evaluation is in progress.No conclusion can be drawn.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 patient underwent a revision surgery on (b)(6) 2017 for the breakage of a trochanteric fixation nail advanced (tfna) of the hip.The patient was revised to a hemiarthroplasty.The implant removal was difficult due to the nature of blastic bone, however, no fragments were generated and there was no surgical delay.Procedure was completed successfully.Patient outcome is stable.Patient was implanted with the nail, helical blade and distal locking screw about a year ago at a different facility with a different doctor.Concomitant devices reported: trochanteric fixation nail advanced (tfna) helical blade 90 mm (part # 04.038.290, quantity # 1), distal locking screw (quantity # 1).This report is for one (1) 10 mm/130 deg ti cann tfna 380 mm/right - sterile.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
Product development investigation was completed.A visual inspection, drawing and device history record review were performed as part of this investigation.The returned implant was inspected at customer quality and the complaint was confirmed.The nail was returned broken, in two pieces at the hole where the helical blade interacts with the nail.Whether this complaint could be replicated is not applicable because the device was returned broken.Upon visual inspection surface damage, consistent with removal surgery was noted in addition to the break at the hole where the helical blade would interface.Drawing were reviewed and were determined to be suitable for the intended design, application and dimensional conformity when used as recommended.Device history records review was completed for part# 04.037.058s, lot# h099372.Manufacturing location: monument , release to warehouse date: may 11, 2016, expiry date: apr 30, 2026.No non-conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Dimensional analysis was not applicated at this time as relevant features are significantly malformed.Material and hardness testing was not applicable at this time as they were tested at the time of manufactured and confirmed to have no issues through the dhr review.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 concomitant devices were received without an alleged complaint condition.Upon visual inspection, there is no evidence that this device contributed to the complaint condition.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
Correction to concomitant devices: tfna helical blade 90mm (part 04.038.290, serial/lot (b)(4), quantity 1); 5.0 ti locking screw (part/lot unknown, quantity 1).

• Brand Name: 10MM/130 DEG TI CANN TFNA 380MM/RIGHT - STERILE
• Common Device Name: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7059766
• Report Number: 1719045-2017-50007
• Device Sequence Number: 11241790
• Product Code: HSB
• UDI-Device Identifier: 10886982096142
• UDI-Public: (01)10886982096142(17)260430(10)H099372
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2026
• Device Model Number: 04.037.058S
• Device Catalogue Number: 04.037.058S
• Device Lot Number: H099372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2017
• Initial Date Received by Manufacturer: 10/30/2017
• Supplement Date Received by Manufacturer: 11/28/2017; 12/27/2017
• Initial Report FDA Received Date: 11/27/2017
• Supplement Report FDA Received Date: 12/05/2017; 12/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR