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

Model Number	04.037.161S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Pain (1994); Impaired Healing (2378); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Manufacturing date: july 11, 2018; expiration date: may 31, 2028; part: 04.037.161s, 11mm/130 deg ti cann tfna 400mm / left ¿ sterile; lot: h677630 (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.Sterilization control number (scn) 15211 supplied by ees (albuquerque) 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 parts reviewed: part: 04.037.942.2, lock prong, 130 degree, tfna bp55; lot: l894350 quantity 3 / l910462 quantity 3; lot quantity: 191 total / 96 (l894350) and 95 (l910462).Purchased finished goods travelers met all inspection acceptance criteria.Part: 04.037.912.4, wave spring, shim ended bp55; lot: h571503; 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 (b)(4) were reviewed and determined to be conforming.Part: 04.037.912.3, tfna lock drive bp58; lot: h671543 quantity 1 / h645420 quantity 5; lot quantity: 160 total / 80 (h671543) and 80 (h645420).Work order travelers met all inspection acceptance criteria.Inspection sheets met all inspection acceptance criteria.Part: 21127, timoagri16.00 bp80; lot: h258444; lot quantity: 2,322 lbs.Certificate of test supplied by ati specialty materials was reviewed and determined to be conforming.Lot summary report met all inspection acceptance criteria.Raw material receiving/putaway checklist met all inspection acceptance criteria.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.(b)(4).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) 2019, the patient underwent revision surgery of a femur fracture due to nonunion, upper thigh pain, delayed healing, and subsequent breaking of one (1) titanium locking screw w/t25 stardrive 2mm for intramedullary nails (im).The screw was one of two distal interlocking screws, but this was the only screw that was broken.The proximal segment of the trochanteric femoral nail advance (tfna) nail was broken above the helical blade/screw junction.Patient status is unknown.Concomitant devices: tfna helical blade (part: unknown, lot: unknown, quantity: 1), titanium locking screw w/t25 stardrive 2mm for im (part: 04.005.532, lot: unknown, quantity: 1).This report is for a titanium (ti) cannulated tfna nail.This is report 1 of 2 for (b)(4).
Event or Problem Description
This (b)(4) captures the post-operative event while (b)(4) was created to capture the intra-operative event.
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.Device history lot.Manufacturing date: 11-jul-2018, expiration date: 31-may-2028, part number: 04.037.161s, 11mm/130 deg ti cann tfna 400mm / left ¿ sterile, lot number: h677630 (sterile).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 parts reviewed: part number: 04.037.942.2, lock prong, 130 degree, tfna bp55, lot number: l894350 / l910462.Part number: 04.037.912.4, wave spring, shim ended bp55, lot number: h571503.Part number: 04.037.912.3, tfna lock drive bp58, lot number: h671543 / h645420.Part number: 21127, timoagri16.00 bp80, lot number: h258444.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.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.
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.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/LEFT - 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: 8492504
• Report Number: 2939274-2019-57358
• Device Sequence Number: 13899011
• Product Code: HSB
• UDI-Device Identifier: 10886982096692
• UDI-Public: (01)10886982096692
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/14/2019

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: 04.037.161S
• Device Catalogue Number: 04.037.161S
• Device Lot Number: H677630
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/14/2019
• Supplement Date Received by Manufacturer: 03/14/2019; 05/01/2019
• Initial Report FDA Received Date: 04/08/2019
• Supplement Report FDA Received Date: 04/08/2019; 05/06/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 55