MAUDE Adverse Event Report: SYNTHES GMBH 10MM/130 DEG TI CANN TFNA 235MM/RIGHT - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	04.037.044S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Unspecified Tissue Injury (4559)
Date of Event	07/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h6: 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.Manufacturing location: monument manufacturing date: 02-feb-2022 expiration date: (b)(6) 2032 part number: 04.037.044s, 10mm/130 deg ti cann tfna 235mm/right ¿ sterile lot number: 667p292 (sterile) lot quantity: 5 this lot met all dimensional, visual 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 on (b)(6) 2023, the surgeon removed a tfna construct from the patient because of soft tissue issues and pain.It is unknown if the hardware caused the soft tissue problems.The construct was implanted approximately 6-9 months ago.No further information is available.This report is for a 10mm/130 deg ti cann tfna 235mm/right ¿ sterile.This is report 1 of 3 for (b)(4).

• Brand Name: 10MM/130 DEG TI CANN TFNA 235MM/RIGHT - STERILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17446502
• Report Number: 8030965-2023-09675
• Device Sequence Number: 14131229
• Product Code: HSB
• UDI-Device Identifier: 10886982096005
• UDI-Public: (01)10886982096005
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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 Catalogue Number: 04.037.044S
• Device Lot Number: 667P292
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2022
• 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: TFNA HELICAL BLADE PERF L100 TAN; UNK - SCREWS: 5.0 MM LOCKING
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 41 YR
• Patient Sex: Male
• Patient Weight: 84 KG