MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12MM/130 DEG TI CANN TFNA 170MM - STERILE; ROD FIXATION INTRAMEDULLARY

Model Number	04.037.242S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight unknown.Date of device breakage is unknown.Implanted date is unknown date in (b)(6) 2017.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested.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 patient was implanted with a trochanteric fixation nail advanced (tfna), nail, helical blade and 5.0 mm distal locking screw in (b)(6) 2017.Patient had healed.X-rays were taken pre-operatively on an unknown date.Patient underwent hardware removal on (b)(6) 2018.During revision surgery it was discovered that the nail was broken.The nail had broken prior to removal.The nail had broken just proximal to the insertion of the helical blade.The nail, helical blade and 5.0 mm distal locking screw was easily removed.There were no issues with the helical blade or the locking screw.Patient was revised to a total hip.There was no surgical delay.The procedure was completed successfully and the patient was reported to be stable.The explanted hardware was discarded by the hospital.Concomitant devices reported: tfna helical blade 120 mm sterile (part # 04.038.320s, lot # 981500, quantity of 1), 5.0 mm distal locking screw (part # unknown, lot # unknown, quantity of 1).This complaint involves one (1) device.This is report 1 of 1 for (b)(4),.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Expiration date.Facility telephone.Date of manufacture.Dhr review was completed.Manufacturing location: monument.Manufacturing date: 11-jan-2017.Expiration date: 30-nov-2026.Part #: 04.037.242s, lot#: h264512 (sterile) - 12mm/130 deg ti cann tfna 170mm - sterile.Quantity 6.Component parts reviewed: part 04.037.912.4 - wave spring, shim ended bp-55 lot - h045964.Part 04.037.942.2 - lock prong, 130 degree, tfna bp-55 lot ¿ l0202796.Part 04.037.912.3 - tfna lock drive bp-58 lot ¿ h198464.Part 21127 - raw material lot bp-80 lot - h127983.Raw material received from supplier perryman company.Certified test report received from perryman company for titanium ingot and certificate of analysis received from metalwerks pmd, inc.Meet specification.Raw material receiving/putaway checklist meet specification.Inspection sheet for tfna assembly inspection and inspection sheet for in-process/inspect dimensional/final met inspection acceptance criteria.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.¿sterility documentation was reviewed and determined to be conforming.¿ 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: 12MM/130 DEG TI CANN TFNA 170MM - 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: 7522000
• Report Number: 2939274-2018-52207
• Device Sequence Number: 1176310
• Product Code: HSB
• UDI-Device Identifier: 10886982097262
• UDI-Public: (01)10886982097262
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2018

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: 04.037.242S
• Device Catalogue Number: 04.037.242S
• Device Lot Number: H264512
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/25/2018
• Supplement Date Received by Manufacturer: 05/21/2018
• Initial Report FDA Received Date: 05/17/2018
• Supplement Report FDA Received Date: 05/31/2018
• 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