MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/130 DEG TI CANN TFNA 420MM/RIGHT - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.037.162S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); 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.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.Investigation summary product was not returned.Based on the information available, it has been determined that no corrective and preventive 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 history lot manufacturing location: (b)(4).Manufacturing date: 05-jan-2018; expiration date: 30-nov-2027; part number: 04.037.162s, 11mm/130 deg ti cann tfna 420mm / right ¿ sterile; lot number: h533125 (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 lppf, lmd/lpf rev d was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.(b)(4) supplied by (b)(4) 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: component parts were not reviewed as the reported complaint condition of ¿removal due to nonunion and conversion to total hip arthroplasty¿ does not indicate breakage of the nail or any of its components.Therefore, review of the component dhrs would not be relevant to the reported complaint condition.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.(b)(4).
Event or Problem Description
It was reported that on (b)(6) 2019, the patient had right intertrochanteric hip nonunion and underwent a conversion to right total hip arthroplasty with removal of hardware.The screw found without difficulty and the distal locking screw removed.The proximal portion of the hip dislocated, and the proximal portion of the nail was obtained and the unknown plate removed.Original implant date happened last (b)(6) 2018.Patient had a hip fracture approximately eight to ten months ago that was fixed with intramedullary (im) nail.Patient had worsening pain when ambulating as well as difficulty walking, pain was quite severe.Patient underwent physical therapy and had pain medications and still having discomfort.It is unknown if there was surgical delay.There was were complications with the surgical outcome.Patient status is unknown.This complaint involves five (5) devices.This report is for one (1) 11mm/130 deg ti cann tfna 420mm/right - sterile.This report is 1 of 5 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.Patient code 3191 used in initial medwatch to capture additional medical/surgical intervention required.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 420MM/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: 8588516
• Report Number: 2939274-2019-57879
• Device Sequence Number: 2346143
• Product Code: HSB
• UDI-Device Identifier: 10886982096708
• UDI-Public: (01)10886982096708
• Combination Product (Y/N): N
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: 04.037.162S
• Device Catalogue Number: 04.037.162S
• Device Lot Number: H533125
• Initial Date Received by Manufacturer: 04/08/2019
• Supplement Date Received by Manufacturer: 06/07/2019
• Initial Report FDA Received Date: 05/07/2019
• Supplement Report FDA Received Date: 06/07/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention