MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 9MM TI CANN TIBIAL NAIL-EX W/PROX BEND 345MM-STERILE; NAIL, FIXATION, BONE

Model Number	04.034.349S
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: 17-jul-2019, expiration date: 31-may-2028, part number: 04.034.349s, 9mm ti cann tibial nail - ex w/prox bend 345mm ¿ sterile, lot number: 11l8393 (sterile), lot quantity: (b)(4).One piece was scrapped in cell, inspect dimensional/laser, for an undersized diameter.Three pieces were scrapped in cell, sterile pack, for unacceptable surface finish, dings / scratches.The remainder of the lot was 100% inspected for these features and was determined to be acceptable.Production order traveler met all inspection acceptance criteria apart from the four pieces noted.Inspection sheet, in-process / inspect dimensional / final met all inspection acceptance criteria apart from the one piece (hole diameter) noted.Packaging label log (pll) lppf was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Material 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 and mal-reduction¿ does not indicate breakage of the nail.Therefore, review of the raw material would not be pertinent tot 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 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) 2020 the patient underwent a revision procedure due to a non-union and mal reduction.During the procedure, the original expert tibial nail was removed and the patient was revised to a new expert tibial nail.The procedure was successfully completed without a surgical delay.Patient status is unknown.This report is for one (1) 9mm ti cann tibial nail-ex w/prox bend 345mm-sterile.This is report 1 of 3 for (b)(4).

• Brand Name: 9MM TI CANN TIBIAL NAIL-EX W/PROX BEND 345MM-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: 11154452
• Report Number: 2939274-2021-00178
• Device Sequence Number: 11788916
• Product Code: JDS
• UDI-Device Identifier: 10886982095114
• UDI-Public: 10886982095114
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K040762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/16/2020

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: 04.034.349S
• Device Catalogue Number: 04.034.349S
• Device Lot Number: 11L8393
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 01/12/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention