MAUDE Adverse Event Report: SYNTHES GMBH MULTIFUNCTION ROD FOR INSERTION INSTRUMENTS; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number	03.168.010
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional narrative: h6: photo investigation: the product was not returned to medtech orthopaedics; however, photos were provided for review.The photo investigation revealed that '( 03.168.010, multifunction rod for insertion insts) had broken.The observed condition of the device was consist with a random component failure that may have been caused by exposure to unintended force.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was (confirmed) as the observed condition of the (multifunction rod for insertion insts) would contribute to the complained device issue.Based on the investigation findings, component failure and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.H3, h4, h6: device history record (dhr) review conducted: part: 03.168.010-us lot: 4348p53 manufacturing site: balsthal release to warehouse: 15-mar-2023 a dhr evaluation was performed for the finished device article # 03.168.010-us lot # 4348p53, and no non-conformances were identified.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 an (b)(6) 2025 the surgeon was using the rod for removal and the tip of the rod snapped off intraoperatively during removal.Plate and screws were removed successfully.There was no adverse patient consequence and no surgical delay.The procedure was completed successfully.
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: photo investigation: the product was not returned to medtech orthopaedics, however photos were provided for review.The photo investigation revealed that (03.168.010, multifunction rod for insertion insts) had broken.The observed condition of the device was consist with a random component failure that may have been caused by exposure to unintended force.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was (confirmed) as the observed condition of the (multifunction rod for insertion insts) would contribute to the complained device issue.Based on the investigation findings, component failure and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history review: part: 03.168.010-us.Lot: 4348p53.Manufacturing site: balsthal.Release to warehouse: 15-mar-2023.A dhr evaluation was performed for the finished device article # 03.168.010-us lot # 4348p53, and no non-conformances were identified.Assessment performed by (b)(6).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: MULTIFUNCTION ROD FOR INSERTION INSTRUMENTS
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): WERK BALSTHAL (CH); dornacherstrasse 20; balsthal 4710 ; SZ 4710
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 21563444
• Report Number: 8030965-2025-02307
• Device Sequence Number: 17250880
• Product Code: KTT
• UDI-Device Identifier: 10886982274519
• UDI-Public: (01)10886982274519(10)4348P53
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K172872
• 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: Other Health Care Professional
• Type of Report: Initial,Followup

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 Catalogue Number: 03.168.010
• Device Lot Number: 4348P53
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/17/2025
• Supplement Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown