MAUDE Adverse Event Report: JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD. 10MM/130 DEG TI CANN TFNA 400MM/LEFT - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	04.037.061S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.(b)(4).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
Device report from synthes reports an event in the united kingdom as follows: it was reported that on an unknown date, the patients tfna nail broke.On (b)(6) 2021 the patient underwent revision surgery, the nail was removed, and a new nail was implanted.There were no fragments generated.This report involves one (1) 10mm/130 deg ti cann tfna 400mm/left - sterile.This is report 1 of 1 for (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.H10 additional narrative: g1: manufacturing site name and address.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.D4: catalog and udi.
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.H3, h4, h6- the complaint was confirmed during investigation.There were no issues during the manufacture of this product that would contribute to this complaint condition.During the investigation, no product design issues, or discrepancies were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.Device history lot manufacturing location: monument, manufacturing date: 03-apr-2019, expiration date: 01-mar-2029, part number: 04.037.061s, 10mm/130 deg ti cann tfna 400mm / left ¿ sterile, lot number: h863912 (sterile) , component part(s) reviewed: part number: 04.037.942.2, lock prong, 130 degree, tfna, lot number: 3l60067, part number: 04.037.912.4, wave spring, shim ended lot number: h761718, part number: 04.037.912.3, tfna lock drive lot number: h840099, part number: 21127, timoagri16.00 bp80 lot number: h846837, 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.

• Brand Name: 10MM/130 DEG TI CANN TFNA 400MM/LEFT - STERILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD.; no. 299, changyang street; suzhou industrial park; suzhou, jiangsu 21512 6; CH 215126
• MDR Report Key: 11930317
• Report Number: 8030965-2021-04526
• Device Sequence Number: 14293534
• Product Code: HSB
• UDI-Device Identifier: 10886982096173
• UDI-Public: (01)10886982096173
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/11/2021

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: 04.037.061S
• Device Catalogue Number: 04.037.061S
• Device Lot Number: H863912
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2021
• Initial Date Received by Manufacturer: 05/11/2021
• Supplement Date Received by Manufacturer: 06/11/2021; 07/21/2021
• Initial Report FDA Received Date: 06/03/2021
• Supplement Report FDA Received Date: 06/14/2021; 08/03/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention