MAUDE Adverse Event Report: SYNTHES GMBH 1.0MM DRILL BIT/MQC FOR THREADED HOLE/61MM

Catalog Number	03.130.102
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, while performing the drilling with the 1.0 mm drill bit, the tip broke off, leaving a small fragment inside the patient's bone.Since it could not be removed, the doctor decided to leave the fragment in place due to the difficulty of extraction and because there would be no problem leaving it in the bone.The remaining portion of the aforementioned drill bit was then removed, and another drill bit of the same specifications, also available in the kit, was used.Despite this, the surgery was successfully completed without any delays.
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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: corrected: g1.Photo investigation: the product was not returned to medtech orthopedics; however, photos were provided for review.The photo investigation revealed that "03.130.102 drill bit ø1 l61/31 f/core hole" was broken at the tip.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.Based on the available evidence, a definitive root cause could not be determined for missing components.The provided evidence was not sufficient to confirm the reported event of "embedded device".Functionality issue cannot be evaluated through a photo investigation.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the "drill bit ø1 l61/31 f/core hole" would contribute to the complained device issue.Based on the investigation findings, the ¿drill bit¿ has ¿broken¿ because of unintended force, 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 orthopedics 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: 03.130.10.Lot: f-38295.Manufacturing site: werk selzach.Supplier: sphinx werkzeuge ag.Release to warehouse date: 06 jun 2023.Expiration date: na.A manufacturing record evaluation was performed for the finished article lot 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.
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: added:d9 the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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: h3, h6: photo investigation the product was not returned to medtech orthopedics; however, photos were provided for review.The photo investigation revealed that "03.130.102 drill bit ø1 l61/31 f/core hole" was broken at the tip.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.Based on the available evidence, a definitive root cause could not be determined for missing components.The provided evidence was not sufficient to confirm the reported event of "embedded device".Functionality issue cannot be evaluated through a photo investigation.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the "drill bit ø1 l61/31 f/core hole" would contribute to the complained device issue.Based on the investigation findings, the ¿drill bit ¿ has ¿broken¿ because of unintended force, 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 orthopedics 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 lot = > part:03.130.10 lot:f-38295 manufacturing site: werk selzach supplier: (b)(4) release to warehouse date: 06 jun 2023 expiration date: na a manufacturing record evaluation was performed for the finished article lot 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.

• Brand Name: 1.0MM DRILL BIT/MQC FOR THREADED HOLE/61MM
• Common Device Name: DRILL BIT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach CO 2425 ; SZ 2425
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 23632443
• Report Number: 8030965-2025-11818
• Device Sequence Number: 18475962
• Product Code: HTW
• UDI-Device Identifier: 07611819683006
• UDI-Public: (01)07611819683006(10)F-38295
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: EXEMPT
• 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: 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: 03.130.102
• Device Lot Number: F-38295
• 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: 11/05/2025
• Supplement Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 11/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/06/2023
• 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: Male