MAUDE Adverse Event Report: SYNTHES GMBH 10MM CANNULATED TAPERED DRILL BIT

Catalog Number	03.037.021
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthes reports an event in canada as follows: it was reported that on (b)(6) 2023, the lag screw drill bit was grinding metal on metal through guide sleeve.There is no patient consequence.This report involves one (1) 10mm cannulated tapered drill bit.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.H10 additional narrative: d10 therapy date: july 24, 2023.H3, h4, h6: part: 03.037.021.Lot no: f-25420.Release to warehouse date:19 nov 2018.Manufacturing site: werk selzach.Supplier: sphinx werkzeuge ag.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that 10mm cannulated tapered drill bit was found blunting/rounding of cutting edges.It is not unreasonable that the condition identified in visual analysis would contribute to a dull condition.The observed condition was consistent as an end of life indicator for the device.No other issues were identified.A functional test was performed with the mating screw only guide sleeve part number 03.037.117 and no sounds/vibration/grinding during the interaction could be detected.The complaint condition was not able to be replicated.The device exhibits damage consistent with repeated use.The lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use, the device must be properly inspected prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed dullness condition of 10mm cannulated tapered drill bit would have contributed to the complained issue.There is no indication that a design or manufacturing issue has caused the complaint condition.It was determined that the reusable instrument was worn from repeated use and servicing.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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.

• Brand Name: 10MM CANNULATED TAPERED DRILL BIT
• Common Device Name: DRILL BIT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18104419
• Report Number: 8030965-2023-14175
• Device Sequence Number: 5556124
• Product Code: HTW
• UDI-Device Identifier: 10886982070371
• UDI-Public: 10886982070371
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Physician
• 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: 03.037.021
• Device Lot Number: F-25420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/26/2023
• Initial Report FDA Received Date: 11/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SCREW ONLY GUIDE SLEEVE; UNK - SCREWS: LAG
• Patient Sex: Unknown