MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12MM/130 DEG TI CANN TFNA 400MM/LEFT-STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	04.037.261S
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.A device history record (dhr) review was conducted: manufacturing location: (b)(4).Manufacturing date: 16-jul-2021.Expiration date: 30-jun-2031.Part number: 04.037.261s, 12mm/130 deg ti cann tfna 400mm/left- sterile.Lot number: 274p153 (sterile).Lot quantity: (b)(4).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: 04.037.912.3, tfna lock drive.Lot number: 231p369.Lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Part number: 04.037.912e3, tfna lock drive.Lot number: 221p909.Lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Inspection sheet, met all inspection acceptance criteria.Part number: 04.037.942.2, lock prong, 130 degree.Lot number: 230p576.Lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Part number: 04.037.942e2, lock prong, 130 degree.Lot number: 197p975.Lot quantity: (b)(4).Six pieces were scrapped in cell, final inspection, due to unacceptable surface finish ¿ dings/scratches.Production order traveler met all inspection acceptance criteria apart from the six pieces noted.Inspection sheet, final inspection, met all inspection acceptance criteria apart from the six pieces noted.Part number: 21127, timoagri16.00.Lot number: 65p1142.Lot quantity: (b)(4).Inspection instruction met all inspection acceptance criteria.Certified test report dated 04-may-2020 was reviewed and determined to be conforming.Lot summary report dated 31-jul-2020 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.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 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, during a procedure, when surgeon was advancing the set screw in the proximal portion of the nail, it would not advance distal enough within the nail to engage with the tfna lag screw.It seemed like it was not centered properly within the nail or was cross threaded.After turning the set screw counter clockwise and hammering on the 5.0mm flexible screwdriver several times the set screw advanced distal enough to engage with the tfna lag screw in the static position.This delayed the case for about fifteen (15) minutes.No further information provided.This report is for one (1) 12mm/130 deg ti cann tfna 400mm/left-sterile.This is report 1 of 2 for complaint (b)(4).

• Brand Name: 12MM/130 DEG TI CANN TFNA 400MM/LEFT-STERILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 12969631
• Report Number: 2939274-2021-07014
• Device Sequence Number: 19937368
• Product Code: HSB
• UDI-Device Identifier: 10886982097415
• UDI-Public: (01)10886982097415
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/11/2021

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: 04.037.261S
• Device Catalogue Number: 04.037.261S
• Device Lot Number: 274P153
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2021
• Initial Report FDA Received Date: 12/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5MM HEX FLEXIBLE SCREWDRIVER; UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: TRAUMA; UNK - NAIL HEAD ELEM: TFNA LAG SCREW; UNK - NAIL HEAD ELEMENTS: SCREW
• Patient Sex: Unknown