MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11 TI CANN TIB NAIL-EX PROX BEND 360-S; NAIL, FIXATION, BONE

Model Number	04.034.552S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
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, as no product was received.Based on the information available, it has been determined that no corrective and/or 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 history lot - manufacturing location: (b)(6), manufacturing date: 04-sep-2019, expiration date: 31-jul-2028, part number: 04.034.552s, 11mm ti cann tibial nail - ex w/prox bend 360mm ¿ sterile, lot number: 15l6379 (sterile), lot quantity: 6.Production order traveler met all inspection acceptance criteria.Inspection sheet, in-process / inspect dimensional / final, ns076208 rev b met all inspection acceptance criteria.Packaging label log (pll) lppf rev g, lmd rev a was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn 16598 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 possible infection¿ 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 - 05-oct-2021: dhr reviewed by: mschoenfeld.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, during a procedure a tibial nail and screws were removed from a patient because of a possible infection.The hardware came out successfully and nail was implanted at (b)(6) in (b)(6) of 2021.This report is for one (1) 11mm ti cann tibial nail-ex w/prox bend 360mm-sterile.This is report 1 of 4 for (b)(4).

• Brand Name: 11 TI CANN TIB NAIL-EX PROX BEND 360-S
• 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: 12700389
• Report Number: 2939274-2021-06309
• Device Sequence Number: 13822985
• Product Code: JDS
• UDI-Device Identifier: 10886982095381
• UDI-Public: (01)10886982095381
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K040762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/28/2021

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 Model Number: 04.034.552S
• Device Catalogue Number: 04.034.552S
• Device Lot Number: 15L6379
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 10/26/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention