MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM TI CANN TIBIAL NAIL-EX W/PROX BEND 405MM-STERILE; NAIL, FIXATION, BONE

Model Number	04.034.461S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing location: (b)(4), manufacturing date: 28-apr-2017, expiration date: 31-mar-2026, part number: 04.034.461s, 10mm ti cann tibial nail - ex w/prox bend 405mm-sterile, lot number: h350699 (sterile), lot quantity: (b)(4).Work order traveler met all inspection acceptance criteria.Inspection sheet, in-process acceptance sheet met all inspection acceptance criteria.Inspection sheet, inspect dimensional met all inspection acceptance criteria.Inspection sheet, final inspection met all inspection acceptance criteria.Packaging label log lppf was reviewed and determined to be conforming.Scn (b)(4) 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: part number: 21012, tialnbri13.00, lot number: h339385, lot quantity: (b)(4).Product certification 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.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.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.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) 2021 the patient underwent a revision surgery due to a non-union of the left tibial shaft.The implants that were removed were titanium cannulated tibial nail, end cap, and three titanium locking screws.There was no surgical delay.The procedure was completed successfully.This report is for one (1) 10mm ti cann tibial nail-ex w/prox bend 405mm-sterile.This is report 5 of 5 for (b)(4).

• Brand Name: 10MM TI CANN TIBIAL NAIL-EX W/PROX BEND 405MM-STERILE
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11894686
• Report Number: 2939274-2021-02643
• Device Sequence Number: 16491168
• Product Code: JDS
• UDI-Device Identifier: 10886982095282
• UDI-Public: 10886982095282
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K040762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/30/2021

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 Expiration Date: 03/31/2026
• Device Model Number: 04.034.461S
• Device Catalogue Number: 04.034.461S
• Device Lot Number: H350699
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/30/2021
• Initial Report FDA Received Date: 05/27/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5.0 TI LCKNG SCR T25 SD 36 FOR IM NAILS; 5.0 TI LCKNG SCR T25 SD 42 FOR IM NAILS; 5.0 TI LCKNG SCR T25 SD 44 FOR IM NAILS; TI END CAP T40 SD 0 EXT F/TI TIB NL-EX
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 83