MAUDE Adverse Event Report: SYNTHES GMBH 3.8MM THREE-FLUTED DRILL BIT QC/CALIBRATED/270MM; BIT, SURGICAL

Catalog Number 03.019.016

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/05/2021

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.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.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 Description

This (b)(4) is related to (b)(4) which reports about pts product.This pc reports about syn product.It was reported that on (b)(6) 2021, the patient underwent the humerus fracture osteosynthesis with the colibri quick coupling (pts) and the drill bit (syn) in question.While drilling multiloc screw, the surgeon found the quick coupling was loose, and the drill bit could not be removed.The surgeon used another quick coupling.Procedure was completed successfully without any surgical delay.This report is for one (1) 3.8mm three-fluted drill bit qc/calibrated/270mm.This is report 1 of 1 for complaint (b)(4).

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: updated data: h4.Investigation summary the product was returned to us cq for evaluation.The us cq team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that drill bit ã¿3.8 cal l270 3flut the threads of the drill bit were slightly deformed, and no other issues were identified.The dimensional inspection was not performed due to post manufacturing damage.The functional test cannot be performed since the device was received by itself, but the functional test of the mating device ao/asif quick coupling for drill bits was performed by the pts team and japan local team confirms the alleged complaint condition.The observed condition drill bit ã¿3.8 cal l270 3flut in the device was consistent with the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for drill bit ã¿3.8 cal l270 3flut.While no definitive root cause could be determined.There was no indication that a design or manufacturing issue contributed to the complaint.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 history lot part: 03.019.016.Lot: u177910.Manufacturing site: selzach.Supplier: orchid bridgeport.Release to warehouse date: 04 june 2013.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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.Corrected data: d9, h3, h6.

• Brand Name: 3.8MM THREE-FLUTED DRILL BIT QC/CALIBRATED/270MM
• Type of Device: BIT, SURGICAL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12421514
• MDR Text Key: 269797793
• Report Number: 8030965-2021-07481
• Device Sequence Number: 1
• Product Code: GFG
• UDI-Device Identifier: 07611819427167
• UDI-Public: (01)07611819427167
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.019.016
• Device Lot Number: U177910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2021
• Date Manufacturer Received: 09/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1