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

Model Number	04.037.059S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.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 (b)(6) 2020 the patient underwent a revision operation for a broken trochanteric fixation nail advances (tfna) nail.The patient had a non union that did not heal.The original date of surgery was (b)(6) 2020.Concomitant devices: unknown tfna helical blade part# unknown; lot# unknown; quantity: 1; unknown locking screws part# unknown; lot# unknown; quantity: unknown).This report is for one (1) 10mm/130 deg ti cann tfna 380mm/left - 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: a1, a2, a3 b5 d4, d6b h3, h4, h6: manufacturing location: monument manufacturing date: september 10, 2019 expiration date: july 31, 2029 part number: 04.037.059s, 10mm/130 deg ti cann tfna 380mm/left ¿ sterile lot number: 16l2002 (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) lppf rev e, lmd 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 part(s) reviewed: part number: 04.037.912.3, tfna lock drive lot number: 14l2693 lot quantity: 150 production order traveler met all inspection acceptance criteria.Inspection sheet met all inspection acceptance criteria.Part number: 04.037.912.4, wave spring, shim ended, bp55 lot number: h794568 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 were reviewed and determined to be conforming.Part number: 04.037.942.2, lock prong 130 degree, tfna lot number: 14l9915 lot quantity: 56 production order traveler met all inspection acceptance criteria.Inspection sheet, final inspection met all inspection acceptance criteria.Part number: 21127, timoagri16.00 lot number: 10l8564 lot quantity: 3,258 lbs.Inspection instruction met all inspection acceptance criteria.Certificate of test was reviewed and determined to be conforming.Lot summary report dated june 19, 2019 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.B3: only event year is known.
Event or Problem Description
It was reported that on (b)(6) 2020, the patient underwent removal of a trochanteric fixation nail advances (tfna) nail due to it was broken.The patient had gone on to a non union and do not heal.The nail was originally implanted on (b)(6) 2020.The surgery was successful with no surgical delay.The surgeon was able to implant another nail from a different company.The patient status is unknown.Concomitant device reported: tfna helical blade (part number unknown, lot unknown, quantity 1) locking screws (part unknown, lot unknown, quantity unknown).

• Brand Name: 10MM/130 DEG TI CANN TFNA 380MM/LEFT - STERILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11108158
• Report Number: 2939274-2021-00003
• Device Sequence Number: 17068326
• Product Code: HSB
• UDI-Device Identifier: 10886982096159
• UDI-Public: 10886982096159
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K131548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2020

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: 04.037.059S
• Device Catalogue Number: 04.037.059S
• Device Lot Number: 16L2002
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/07/2020
• Supplement Date Received by Manufacturer: 01/07/2021
• Initial Report FDA Received Date: 01/04/2021
• Supplement Report FDA Received Date: 01/27/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE; UNK - SCREWS: LOCKING; UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE; UNK - SCREWS: LOCKING
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR