MAUDE Adverse Event Report: SYNTHES GMBH MATRIXMANDIBLE 1.5MM DRILL BIT J-LATCH FOR 03.503.045/.047; DRILL, BONE, POWERED

Catalog Number	03.503.476S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: b3: event occurred on an unknown date in 2023.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.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Part # 03.503.476s.Lot # 111l702.Manufacturing site: werk selzach.Release to warehouse date: 01 dec 2022.Expiration date: 01 dec 2032.Supplier: früh verpackungstechnik ag.Non-sterile part # 03.503.476.Non-sterile lot # u410107.Manufacturing site: werk selzach.Release to warehouse date: 08 aug 2022.Supplier: synthes usa hq, inc.The product was not returned to depuy synthes, however photos were provided for review.The photo investigation revealed that distal portion of the 03.503.476s, matrixmandible drill bit ã¸1.5 2flute f/0 is broken.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the 03.503.476s, matrixmandible drill bit ã¸1.5 2flute f/0 would contribute to the complained device issue.Based on the investigation findings, potential cause can be traced 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.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
Device report from australia reports an event as follows: it was reported that on an unknown date in 2023, the scrub nurse loaded the drill bit into the handpiece and tested the drill outside of the patient.The tip of the drill bit flew off across the room and landed on the floor.A new drill bit was used and the procedure was completed successfully with 2 minutes of surgical delay.All generated fragments were outside of the patient and collected without additional medical intervention.There was no adverse patient impact.No further information is available.This report is for a matrixmandible 1.5mm drill bit j-latch for 03.503.045/.047.This is report 1 of 1 for (b)(4).

• Brand Name: MATRIXMANDIBLE 1.5MM DRILL BIT J-LATCH FOR 03.503.045/.047
• Common Device Name: DRILL, BONE, POWERED
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK SELZACH; bohnackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18222078
• Report Number: 8030965-2023-14934
• Device Sequence Number: 12209482
• Product Code: DZI
• UDI-Device Identifier: 10887587012971
• UDI-Public: (01)10887587012971
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K043310
• 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: Nurse
• 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: 03.503.476S
• Device Lot Number: 111L702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/06/2023
• Initial Report FDA Received Date: 11/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2022
• 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: Unknown