MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM/125 DEG TI CANN TFNA 380MM/RIGHT - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.037.028S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event occurred on an unknown date in 2020.Complainant part is not expected to be returned for manufacturer review/ investigation.(b)(4).The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/ or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 on an unknown date in 2020, the trochanteric fixation nail advanced (tfna) nail broke in the patient.The break was in the helical blade hole in the nail.It is unknown how the issue was discovered.It is unknown if there was a patient consequence.Concomitant device reported: unknown tfna helical blade (part # unknown, lot # unknown, quantity 1), unknown tfna end cap (part # unknown, lot # unknown, quantity 1), unknown locking screw (part # unknown, lot # unknown, quantity unknown).This report is for one (1) 10mm/ 125 deg ti cann tfna 380mm/ right - sterile.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.H3, h6: manufacturing location: monument, manufacturing date: 22-jun-2018, expiration date: 31-may-2028, part number: 04.037.028s, 10mm/125 deg ti cann tfna 380mm/right¿ sterile, lot number: h666501 (sterile), lot quantity: 6.Work order traveler met all inspection acceptance criteria.Inspection sheet, in-process / inspect dimensional / final met all inspection acceptance criteria.Inspection sheet, tfna assembly inspection, met all inspection acceptance criteria.Packaging label log (pll) was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn 15171 supplied by ethicon (abq) was reviewed and determined to be conforming.This lot met all dimensional, visual, sterilization and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component parts reviewed: part number: 04.037.912.2, lock prong 125 degree, tfna, bp55, lot number: l900593, lot quantity: 96.Purchased finished goods traveler met all inspection acceptance criteria.Part number: 04.037.912.4, wave spring, shim ended, bp55, lot number: h571496, lot quantity: 1,000.Work order traveler met all inspection acceptance criteria inspection sheet, incoming final inspection met all inspection acceptance criteria.Material certification and certificate of conformance and quality history card received from smalley dated 02-may-2018 were reviewed and determined to be conforming.Part number: 04.037.912.3, tfna lock drive, bp58, lot number: h634296, lot quantity: 80.Work order traveler met all inspection acceptance criteria.Inspection sheet met all inspection acceptance criteria.Part number: 21127, timoagri16.00, bp80, lot number: h618214, lot quantity: 2,847 lbs.Certificate of analysis received from metalwerks dated 27-mar-2018 was reviewed and determined to be conforming.Lot summary report dated 12-apr-2018 met all inspection acceptance criteria.Raw material receiving / putaway checklist met all inspection acceptance criteria.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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/125 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: 10376384
• Report Number: 2939274-2020-03419
• Device Sequence Number: 19613047
• Product Code: HSB
• UDI-Device Identifier: 10886982095862
• UDI-Public: (01)10886982095862
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2020

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: 04.037.028S
• Device Catalogue Number: 04.037.028S
• Device Lot Number: H666501
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/16/2020
• Supplement Date Received by Manufacturer: 08/10/2020
• Initial Report FDA Received Date: 08/06/2020
• Supplement Report FDA Received Date: 09/03/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - END CAPS: TFNA; UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE; UNK - SCREWS: LOCKING
• Outcome Attributed to Adverse Event: Required Intervention