MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM TI CANNULATED TIBIAL NAIL-EX/345MM-STERILE; NAIL,FIXATION,BONE

Model Number	04.004.549S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2020
Type of Reportable Event	Malfunction
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)(4), manufacturing date: april 29, 2020, expiration date: march 31, 2029, part number: 04.004.549s, 11mm ti cannulated tibial nail ¿ ex/345mm-sterile, lot number: 53p5885 (sterile).Production order traveler met all inspection acceptance criteria.Inspection sheet, in-process / inspect dimensional / final, ns072581 rev a met all inspection acceptance criteria.Packaging label log (pll) lppf rev j, 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 (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: 13l9337.Inspection instruction met all inspection acceptance criteria.Certified test report supplied by (b)(4) dated 28-jun-2019 and certificate of test supplied to (b)(4) dated 25-jul-2018 were reviewed and determined to be conforming.Lot summary report dated 30-jul-2019 met all inspection acceptance criteria.Raw material receiving/putaway checklist met all inspection acceptance criteria.Device history review: 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 an expert tibial nail insertion procedure on (b)(6) 2020, the drill bit made contact with nail while drilling for the proximal screw.The device was checked after the procedure and showed everything was correctly aligned.The procedure was successfully completed with two (2) minutes surgical delay.There was no patient consequence.Patient status is unknown.Concomitant device reported: unknown screws (part # unknown, lot # unknown, quantity unknown).This report is for one (1) 11mm ti cannulated tibial nail-ex/345mm-sterile.This is report 5 of 6 for (b)(4).

• Brand Name: 11MM TI CANNULATED TIBIAL NAIL-EX/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: 10944102
• Report Number: 2939274-2020-05441
• Device Sequence Number: 19625723
• Product Code: JDS
• UDI-Device Identifier: 10886982084491
• UDI-Public: (01)10886982084491
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K040762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.004.549S
• Device Catalogue Number: 04.004.549S
• Device Lot Number: 53P5885
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/08/2020
• Supplement Date Received by Manufacturer: 12/28/2020
• Initial Report FDA Received Date: 12/04/2020
• Supplement Report FDA Received Date: 12/30/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 12.0MM/8.0MM PROTECTION SLEEVE 188MM; 8.0MM/4.2MM DRILL SLEEVE 200MM; AIMING ARM FOR SUPRAPATELLAR; INSERTION HANDLE FOR SUPRAPATELLAR; UNK - DRILL BITS: TRAUMA; UNK - SCREWS: TRAUMA; 12.0MM/8.0MM PROTECTION SLEEVE 188MM; 8.0MM/4.2MM DRILL SLEEVE 200MM; AIMING ARM FOR SUPRAPATELLAR; INSERTION HANDLE FOR SUPRAPATELLAR; UNK - DRILL BITS: TRAUMA; UNK - SCREWS: TRAUMA
• Patient Age: 33 YR