MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/130 DEG TI CANN TFNA 360MM/RIGHT - STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.037.156S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is expected to be returned for manufacturer review/ investigation, but has yet to be received.(b)(4).The investigation could not be completed; no conclusion could be drawn at the time of filing this report.A review of the device history record 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 on (b)(6) 2020, the patient underwent a revision of a broken trochanteric fixation nail - advance (tfn-advance).The procedure was successfully completed.Patient status was stable.Concomitant device reported: unknown helical blade (part #: unknown, lot #: unknown, quantity 1), unknown locking screw (part #: unknown, lot #: unknown, quantity 2).This report is 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.Manufacturing location: monument, manufacturing date: august 26, 2019, expiration date: july 31, 2029, part number: 04.037.156s, 11mm/130 deg ti cann tfna 360mm/right- sterile, lot number: 12l4284 (sterile), lot quantity: 5.One piece was scrapped in cell, due to a cannulation run-out failure.The remainder of the lot was 100% inspected for this feature and determined to be acceptable.Dispositioned as rework for ultrasonic clean and final rinse.The parts were reinspected after rework and determined to be acceptable.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.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: 04.037.942.2, lock prong, 130 degree tfna, lot number: 5l09636, lot quantity: 95.Production order traveler met all inspection acceptance criteria.Part number: 04.037.912.4, wave spring, shim ended lot number: h794576, lot quantity: 1,000.Production order and work order travelers 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 and dated february 20, 2019 were reviewed and determined to be conforming.Part number: 04.037.912.3, tfna lock drive lot number: 12l2942, lot quantity: 150.Production order traveler met all inspection acceptance criteria.Inspection sheet met all inspection acceptance criteria.Part number: 21127, timoagri16.00, bp80, lot number: 3l28792, lot quantity: 2,864 lbs.Inspection instruction met all inspection acceptance criteria.Certificate of analysis supplied and dated april 9, 2019 was reviewed and determined to be conforming.Lot summary report dated may 17, 2019 met all inspection acceptance criteria.Raw material receiving/putaway checklist met all inspection acceptance criteria.March 19, 2020: dhr 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 11mm/130 deg ti cann tfna 360mm/right - sterile (p/n 04.037.156s lot 12l4284) was received at customer quality (cq).Upon visual inspection, the complaint device was broken at the helical blade slot.Drill marks observed around the point of breakage.The proximal head of the nail, above the point of breakage, has some scratches, which is consistent with cosmetic damage only.The distal end of the nail has drill marks near the most proximal opening/hole/slot.No other visual issues were identified with the returned components of the device.Device failure/defect identified? yes.Dimensional inspection: drawing specified dimensions: proximal head od = 15.66mm +/- 0.1mm measured dimensions: proximal head od, above break = conforming proximal head od, below break = conforming device used ¿ caliper ca802.Document/specification review: current and manufactured were reviewed.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.Conclusion: the complaint was confirmed during investigation.There were no issues during the manufacture of this product that would contribute to this complaint condition.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.Due to the received condition, it could not be determined during investigation whether the drill marks caused or contributed to the break.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.
Event or Problem Description
Concomitant device reported: tfna fenestrated helical blade 90mm (part: 04.038.390, lot: h323826, quantity 1) unknown locking screw (part: unknown, lot: unknown, quantity 2).

• Brand Name: 11MM/130 DEG TI CANN TFNA 360MM/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: 9931131
• Report Number: 2939274-2020-01752
• Device Sequence Number: 2416349
• Product Code: HSB
• UDI-Device Identifier: 10886982096647
• UDI-Public: (01)10886982096647
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2020

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: 04.037.156S
• Device Catalogue Number: 04.037.156S
• Device Lot Number: 12L4284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2020
• Initial Date Received by Manufacturer: 03/10/2020
• Supplement Date Received by Manufacturer: 04/21/2020
• Initial Report FDA Received Date: 04/06/2020
• Supplement Report FDA Received Date: 05/05/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 11MM/130 DEG TI CANN TFNA 360MM/RIGHT - STERILE; TFNA FENESTRATED HELICAL BLADE 90MM; UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 87 YR
• Patient Weight: 64