MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12/130 DEG TI CANN TFNA 400/LEFT-STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 04.037.261S

Device Problem Break (1069)

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

Part is expected to be returned for manufacturer review/ investigation, but has yet to be received.Reporter is a j&j sales representative.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 Description

It was reported that on an unknown postoperative date the trochanteric fixation nail-advanced (tfna) nail broke.The patient had a non union of the left.The patient underwent the revision surgery on (b)(6) 2021 to remove the broken nail and replace it with a larger nail.Patient outcome is unknown.This report is for one (1) 12mm/130 deg ti cann tfna 400mm/left-sterile.This is report 1 of 1 for complaint (b)(4).

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.Manufacturing location: monument manufacturing date: (b)(6) 2019.Expiration date: (b)(6) 2029.Part number: 04.037.261s, 12mm/130 deg ti cann tfna 400mm/left- sterile lot number: 29p1703 (sterile) lot quantity: 5 production order traveler met all inspection acceptance criteria apart from the one piece noted.Inspection sheet, in-process / inspect dimensional / final met all inspection acceptance criteria apart from the one piece noted.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 16938 supplied by ethicon (abq) was reviewed and determined to be conforming.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.Component part(s) reviewed: part number: 04.037.912.3, tfna lock drive lot number: 25p9897 lot quantity: 200 production order traveler met all inspection acceptance criteria apart from the one piece noted.Inspection sheet met all inspection acceptance criteria apart from the one piece noted.Part number: 04.037.912.4, wave spring, shim ended lot number: 17p1865 lot quantity: 1,000 production order traveler met all inspection acceptance criteria.Inspection sheet, incoming final inspection met all inspection acceptance criteria.Material certificate 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 lot number: 19p2724 lot quantity: 66 production order traveler met all inspection acceptance criteria.Part number: 21127, timoagri16.00 lot number: 16l3712 lot quantity: 1,045 lbs.Inspection instruction met all inspection acceptance criteria.Certified test report and certificate of test were reviewed and determined to be conforming.Lot summary report dated 30-aug-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.Visual inspection: the 12/130 deg ti cann tfna 400/left-sterile (part #: 04.037.261s, lot #: 29p1703) was received at us customer quality (cq).Upon visual inspection, the device was broken at the proximal hole.The drill marks were observed inside the hole near the broken section of the nail.The scratches were also visible all across the surface of nail that are consistent with implantation/explantation of the device.Device failure/defect identified? yes dimensional inspection: the od was measured twice at each side of where the crack occurred measured dimensions: shaft big od = conforming document/specification review: current and manufactured were reviewed.No design issues or discrepancies were identified.Complaint confirmed? yes investigation conclusion: this complaint is confirmed as the 12/130 deg ti cann tfna 400/left-sterile was received being broken at the proximal hole.Although no definitive root cause could be determined based on the provided information, it is likely that the device experienced unintended forces during use.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.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: 12/130 DEG TI CANN TFNA 400/LEFT-STERILE
• Type of Device: 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: 12418073
• MDR Text Key: 270481926
• Report Number: 2939274-2021-05157
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982097415
• UDI-Public: (01)10886982097415
• Combination Product (y/n): N
• PMA/PMN Number: K160167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/04/2021

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
• Device Operator: Health Professional
• Device Model Number: 04.037.261S
• Device Catalogue Number: 04.037.261S
• Device Lot Number: 29P1703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2021
• Initial Date Manufacturer Received: 08/04/2021
• Initial Date FDA Received: 09/02/2021
• Supplement Dates Manufacturer Received: 09/07/2021
• Supplement Dates FDA Received: 09/28/2021
• Patient Sequence Number: 1
• Treatment: UNK - END CAPS: TFNA; UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE; UNK - SCREWS: NAIL DISTAL LOCKING
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR