MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM/130 DEG TI CANN TFNA 235MM/RIGHT - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.037.044S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j representative.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 for a tfna removal where the blade has migrated medial.It is unknown if the procedure was completed successfully.Patient status is unknown.Concomitant device reported: unk - locking screw (part#: unknown, lot#: unknown, quantity: 1).This complaint involves two (2) devices.This report is for (1) 10mm/130 deg ti cann tfna 235mm/right - sterile.This report is 1 of 2 of (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Manufacturing location: monument.Manufacturing date: march 18, 2021.Expiration date: february 28, 2031.Part number: 04.037.044s, 10mm/130 deg ti cann tfna 235mm/right ¿ sterile.Lot number: 94p5016 (sterile).Lot quantity: (b)(4).Two pieces were scrapped, sterile pack, for burrs in diameters.Production order traveler met all inspection acceptance criteria apart from the two pieces noted.Inspection sheet, in process / inspect dimensional / final, met all inspection acceptance criteria.Inspection sheet, tfna assembly inspection, met all inspection acceptance criteria.Packaging label log was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.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 blade migration¿ 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.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.

• Brand Name: 10MM/130 DEG TI CANN TFNA 235MM/RIGHT - STERILE
• Common Device Name: ROD,FIXATION,INTRAMEDULLARY
• 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 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12647293
• Report Number: 2939274-2021-06139
• Device Sequence Number: 19260626
• Product Code: HSB
• UDI-Device Identifier: 10886982096005
• UDI-Public: (01)10886982096005
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.037.044S
• Device Catalogue Number: 04.037.044S
• Device Lot Number: 94P5016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2021
• Supplement Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 10/18/2021
• Supplement Report FDA Received Date: 11/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TFNA FENESTRATED HELICAL BLADE 105MM; UNK - SCREWS: LOCKING; TFNA FENESTRATED HELICAL BLADE 105MM; UNK - SCREWS: LOCKING
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male