MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/130 DEG TI CANN TFNA 400MM/RIGHT - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.037.160S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); Not Applicable (3189)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient height reported as 170.0 cms.Date of implant reported as (b)(6) 2017, exact date is not known.Complainant part is not expected to be returned for manufacturer review/investigation.A review of the device history records has been requested.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 underwent a trochanteric fixation nail advanced (tfna) nail removal on (b)(6) 2018, due to a broken nail and to reduce the non-union.Originally, the tfna nail was implanted on october 2017 to treat a pathologic fracture and after seven months, the patient had a non-union.The surgeons removed the broken nail to reduce the non-union into a better position and reinserted a competitor¿s intertrochanteric antegrade nail.It was unknown if there was a surgical delay.No patient outcome reported.Concomitant devices reported: tfna helical blade (part number unknown, lot number unknown, quantity 1); distal locking screw (part number unknown, lot number unknown, quantity unknown).This report is for one (1) 11mm 130 degree tfna nail.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.A device history record (dhr) review was conducted for part #: 04.037.160s, lot #: h375033 (sterile) - 11mm/130 deg ti cann tfna 400mm/right - sterile.Lot quantity: 6.Manufacturing location: monument, manufacturing date: 31-may-2017, expiration date: 30-apr-2027: dhr review identified a planned nonconformance during the review.Work order traveler was processed using planned final inspection.This planned nc will allow operators to no longer measure the notch depth feature at final inspection.This was due to the gage damaging the spring tabs on the parts when used at final inspection.The notch depth will continue to be measured with a 100% inspection frequency at mill id.Operators will line through and n/a the notch depth inspection item on the inspection sheet and cite this nonconformance number on the inspection sheet.Inspection sheet, in process/inspect dimensional/final recorded at op 160 final inspection for notch depth.This planned nr would not have contributed to the complaint condition because it only removes an inspection at final that is already being performed at 100% on an earlier operation.Thus, this would not impact the final accepted product.Inspection sheet, tfna assembly instruction met all inspection acceptance criteria.Packaging label log lppf, lmd/lpf rev c was reviewed and found to be conforming.Packaging bom indicates that all packaging used met current specifications.Scn supplied by ees (albuquerque) was reviewed and found to be conforming.Component parts reviewed: 04.037.942.2 - lock prong, 130 degree, tfna bp-55 lot #: l367715, lot quantity: 96: purchased finished goods traveler met all inspection acceptance criteria.Part 04.037.912.4 - wave spring, shim ended bp-55 lot #: h249502, 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 supplied by smalley dated 31-mar-2017 was reviewed and found to be conforming.Part 04.037.912.3 - tfna lock drive bp-58 lot #: h363662, lot quantity: 80: work order traveler met all inspection acceptance criteria.Inspection sheet met all inspection acceptance criteria.Part 21127 ¿ timoagri16.00 bp-80 lot #: h210699 certificate of analysis received from metalwerks pmd, inc dated 20-sep-2016 was reviewed and found to be conforming.Lot summary report met all inspection acceptance criteria.Raw material receiving/putaway checklist met all inspection acceptance criteria.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: 11MM/130 DEG TI CANN TFNA 400MM/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: 7740644
• Report Number: 2939274-2018-53164
• Device Sequence Number: 1050045
• Product Code: HSB
• UDI-Device Identifier: 10886982096685
• UDI-Public: (01)10886982096685
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2018

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: 04.037.160S
• Device Catalogue Number: 04.037.160S
• Device Lot Number: H375033
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/17/2018
• Supplement Date Received by Manufacturer: 08/05/2018
• Initial Report FDA Received Date: 08/01/2018
• Supplement Report FDA Received Date: 08/06/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Weight: 113