MAUDE Adverse Event Report: Synthes GmbH 2.5MM DRILL BIT QC 170MM 80MM CALIBRATION; BIT, DRILL

Catalog Number	03.133.103
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the doctor proceeded to drill the cortex using a 2.5 mm drill bit; the tip snapped while pressure was being applied to drill.The specialist was unable to retrieve this small fragment.The surgery concluded without any further issues or complications.There was no patient harm and no surgical delay.
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 depuy synthes, however photos were provided for review.The photo investigation revealed that drill bit ø2.5 qc l170 calibration 80 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 drill bit ø2.5 qc l170 calibration 80 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 depuy synthes 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: manufacturing location: inspected, packaged, sterilized and released by: monument / supplier- orchid unique manufacturing date: 11-aug-2022 part number: 03.133.103s, 2.5mm drill bit qc 170mm ster 80mm calibration lot number: 1491p80 lot quantity: 100 nonconformance noted: n/a review of the dhr file: production order traveler met all inspection acceptance criteria.Packaging label logs (pll) lmd were reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.A manufacturing record evaluation was performed for the finished device with batch number 1491p80.No nonconformities or manufacturing irregularities have identified related to the complaint condition.Component part(s) reviewed: part number: 03.133m103, 2.5mm drill bit qc 170mm lot number: u414830 lot quantity: 478 inspection instruction met all inspection acceptance criteria.Inspection sheet, incoming final inspection met all inspection acceptance criteria.Certificate of conformance dated 01-aug-2022 was reviewed and determined to be conforming.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 2.5MM DRILL BIT QC 170MM 80MM CALIBRATION
• Common Device Name: BIT, DRILL
• 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 ; 700 orthpaedic dr.; warsaw, IN 46581 ; +1(908)386-3534
• MDR Report Key: 50216043
• Report Number: 8030965-2026-08076
• Device Sequence Number: 14983071
• Product Code: HTW
• UDI-Device Identifier: 10886982269621
• UDI-Public: (01)10886982269621(10)1491P80
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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

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: 03.133.103
• Device Lot Number: 1491P80
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/20/2026
• Initial Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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