MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/125 DEG TI CANN TFNA 440MM/LEFT - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.037.135S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional narrative: 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: monument manufacturing date: jul 16, 2018, expiration date: may 31, 2028, part number: 04.037.135s, 11mm/125 deg ti cann tfna 440mm/left- sterile, lot number: h679582 (sterile), lot quantity: 6, work order traveler met all inspection acceptance criteria.Inspection sheet, in-process / inspect dimensional / final ns071291 rev d met all inspection acceptance criteria.Inspection sheet, tfna assembly inspection ns067861 rev b 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 15128 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: component parts were not reviewed as the reported complaint condition of ¿removal due to non-union¿ does not indicate breakage of the nail or any of its components.Therefore, review of the raw materials would not be pertinent to the reported complaint condition.Device history review 28-aug-2020: dhr reviewed 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.
Event or Problem Description
It was reported that on (b)(6) 2020, a hardware removal was performed due to nonunion.The surgeon removed all tfna parts and replaced with zimmer nail.Other interventions required removal surgery, revision, ria on the contralateral femur for a bone graft.Less than desirable outcome nonunion and delayed healing.The original date of implantation was on (b)(6) 2020.There was no surgical delay reported.The procedure was successfully completed.Patient status outcome tfna removed.This complaint involves four (4) devices.This report is for (1) 11mm/125 deg ti cann tfna 440mm/left - sterile this is report 1 of 3 pc (b)(4).

• Brand Name: 11MM/125 DEG TI CANN TFNA 440MM/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: 10547557
• Report Number: 2939274-2020-04176
• Device Sequence Number: 14201426
• Product Code: HSB
• UDI-Device Identifier: 10886982096494
• UDI-Public: (01)10886982096494
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/21/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 04.037.135S
• Device Catalogue Number: 04.037.135S
• Device Lot Number: H679582
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/21/2020
• Initial Report FDA Received Date: 09/17/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TFNA FENESTRATED SCREW 95MM; UNK - SCREWS: LOCKING
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR