MAUDE Adverse Event Report: SYNTHES GMBH 1.1MM DRILL BIT/MQC FOR THREADED HOLE/56MM

Catalog Number	03.130.202
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the drill bits broke when drilling, one remained inside the patient.
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 '03.130.202, 1.1 drill bit/mqc for threaded hole/56 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.The investigation was not able to confirm the allegation of embedded device as no x-rays were provided to evaluate the condition.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the 1.1 drill bit/mqc for threaded hole/56 would contribute to the complained device issue.Based on the investigation findings, potential cause attributed to 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: 03.130.202 synthes lot : u394344 supplier lot : u394344 release to warehouse date:01 mar 2022 supplier: (b)(4) no ncr's generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 1.1MM DRILL BIT/MQC FOR THREADED HOLE/56MM
• Common Device Name: DRILL BIT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: elba bello ; 1302 wrights lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 23057874
• Report Number: 8030965-2025-09348
• Device Sequence Number: 18334438
• Product Code: HTW
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,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: 03.130.202
• Device Lot Number: U394344
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/14/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/28/2025
• Supplement Date Received by Manufacturer: 09/14/2026; 09/21/2026
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 09/16/2026; 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2022
• 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: Male