MAUDE Adverse Event Report: SYNTHES GMBH TAP FOR 3.5MM CORTEX SCREWS GOLD/110MM; DRILLS, BURRS, TREPHINES & ACCESSORIES (MANUAL)

Catalog Number	311.320
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/07/2023
Type of Reportable Event	Malfunction
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: 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.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 patient underwent open reduction internal fixation (orif) surgery for oblique fracture of the tibial tubercle with tap for cortex screw 3.5mm.Compression fixation between bone fragments was performed using the lag screw method with cortex screw 3.5mm.The surgeon performed the tapping after the drill was complete.In doing so, he kept pushing and turning the handle with the tap displaced from the hole on the contralateral side.As a result, excessive force was applied to the tap and the tip of the tap was damaged.About 1/3 of the tip of the tap was remained in the patient's medullary cavity.The surgeon determined that extraction would be difficult and continued with plate fixation.The surgeon completed the tibial plate fixation.The surgeon also informed the patient about what remained in the body postoperatively.The surgery was completed successfully without any surgical delay.Patient was listed as stable concomitant device reported: unk - plates: trauma (part# unknown, lot# unknown, quantity 1).Unk - screws: 3.5 mm cortex (part# unknown, lot# unknown).This report is for one tap for 3.5mm cortex screws gold/110mm 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.H4, h6: device history record (dhr) review conducted: part# 311.320, lot # 9619523, manufacturing site: werk bettlach , supplier: na, release to warehouse date: 06 nov 2015, expiration date: na.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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: TAP FOR 3.5MM CORTEX SCREWS GOLD/110MM
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (MANUAL)
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17401174
• Report Number: 8030965-2023-09350
• Device Sequence Number: 7721652
• Product Code: HWX
• UDI-Device Identifier: 10886982187345
• UDI-Public: (01)10886982187345
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K153587
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• 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: 311.320
• Device Lot Number: 9619523
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2023
• Supplement Date Received by Manufacturer: 10/03/2023
• Initial Report FDA Received Date: 07/26/2023
• Supplement Report FDA Received Date: 10/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2015
• 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: UNK - PLATES: TRAUMA; UNK - SCREWS: 3.5 MM CORTEX
• Patient Age: 62 YR
• Patient Sex: Male