MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM/130 DEG TI CANN TFNA 320MM/RIGHT - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.037.052S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional patient¿s identifier: (b)(6).Patient¿s weight is unknown.Date of event: date of postoperative nail breakage is unknown.Implanted date: date of original implant is unknown.The subject 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 a patient underwent a trochanteric fixation nail advanced (tfna) hardware removal and revision on (b)(6) 2017.The original procedure was performed on an unknown date.Subsequently, it was discovered that the patient may have fallen and the nail and the distal locking screw had broken.Removed hardware included one nail (broken at the level of the lag screw) and the lag screw(intact).The distal locking screw was found broken, and was left behind in the patient.The surgeon decided that there would be more damage to the soft tissue to remove it.The patient was revised to a stryker total hip prosthesis.Nothing untoward occurred during the procedure.The procedure was completed successfully with the patient in stable condition.Concomitant device reported: tfna screw 95mm (part # 04.038.095, lot # 7978175, quantity 1).This report is for one (1) 10mm/130 deg ti cann tfna 320mm/right - sterile this is report 1 of 2 for complaint (b)(4).
Additional Manufacturer Narrative
Manufacturing site: (b)(4) manufacturing date: april 11, 2016.Product expiration date: march 31, 2028.Sterility documentation was reviewed and determined to be conforming.The finished goods lot, components, raw material documentation and inspection sheet were reviewed and met specification.No non-conformance reports were generated during production.Review of the device history records (dhr) showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.A product investigation was completed: 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.A visual inspection, drawing and device history record review were performed as part of this investigation.Dimensional analysis is not applicated at this time as relevant features are significantly malformed.Material and hardness testing is not applicable at this time as they were tested at the time of manufactured and confirmed to have no issues through the dhr review.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.The relevant drawings were reviewed and were determined to be suitable for the intended design, application and dimensional conformity when used as recommended.During the investigation, no product design issues or discrepancies were observed that may have 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.

• Brand Name: 10MM/130 DEG TI CANN TFNA 320MM/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: 7074661
• Report Number: 1719045-2017-50008
• Device Sequence Number: 1013723
• Product Code: HSB
• UDI-Device Identifier: 10886982096081
• UDI-Public: (01)10886982096081(17)280331(10)H077254
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 11/01/2017

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 Model Number: 04.037.052S
• Device Catalogue Number: 04.037.052S
• Device Lot Number: H077254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2017
• Initial Date Received by Manufacturer: 11/01/2017
• Supplement Date Received by Manufacturer: 12/28/2017
• Initial Report FDA Received Date: 12/01/2017
• Supplement Report FDA Received Date: 12/29/2017
• 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: 76 YR