MAUDE Adverse Event Report: SYNTHES GMBH 2.0MM DRILL BIT QC 140MM STER 60MM CALIBRATION; BIT, DRILL

Model Number	03.133.101S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from japan reports an event as follows: it was reported that on (b)(6) 2022, the patient underwent the orif surgery for distal humerus fracture with the va-dhp.During the procedure, the drill bit in question was broken while drilling for lateral plate installation after medial plate implantation.The fragment of the broken drill bit was removed by the surgeon, no fragments were left in the body.The surgery was completed successfully with a delay of 30 minutes.No further information is available.This report is for a 2.0mm drill bit qc 140mm ster 60mm calibration.This is report 1 of 1 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is a synthes employee.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.This lot met all dimensional, visual, sterility and packaging criteria with no issues documented during the inspection or release of the product that would contribute to this complaint condition.Manufacturing location: inspected, packaged, sterilized and released by: monument / supplier- orchid unique.Release to warehouse date: 28-dec-2020.Expiration date: 01-dec-2030.Part number: 03.133.101s, 2.0mm drill bit qc 140mm ster 60mm calibration.Lot number: 80p5259 (sterile).Lot quantity: 111.Component part(s) reviewed: part number: 03.133.101, 2.0mm drill bit qc 140mm.Lot number: u365066.Lot quantity: 511.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: 2.0MM DRILL BIT QC 140MM STER 60MM 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: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15311801
• Report Number: 8030965-2022-06077
• Device Sequence Number: 2658670
• Product Code: HTW
• UDI-Device Identifier: 10886982277374
• UDI-Public: (01)10886982277374
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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

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 Model Number: 03.133.101S
• Device Catalogue Number: 03.133.101S
• Device Lot Number: 80P5259
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2022
• Initial Report FDA Received Date: 08/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - PLATES: VA-LCP DISTAL HUMERUS; UNK - SCREWS: DISTAL HUMERUS
• Patient Sex: Unknown