MAUDE Adverse Event Report: SYNTHES GMBH 2.5MM DRILL BIT QC 170MM 80MM CALIBRATION; BIT, DRILL

Catalog Number 03.133.103

Device Problem Failure to Cut (2587)

Patient Problem Insufficient Information (4580)

Event Date 04/13/2023

Event Type  malfunction  

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: april 13, 2023.H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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

Device report from synthes reports an event in colombia as follows: it was reported that during a procedure on (b)(6) 2023, a patient suffered friction burns from removal of titanium elastic nails (ten).The extraction clamp was in poor condition and did not properly grasp the nails, resulting in increased manipulation and macerating of the tissue.Soft tissue debridement was performed and bactigrass was placed on the burn.Patient was undergoing extraction of the tens nail due to consolidated osteosynthesis.This report involves one (1) 2.5mm drill bit qc 170mm 80mm calibration.This is report 4 of 5 for (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.H3, h4, h6: part 03.133.103, lot u392201: manufacturing location: supplier: (b)(4).Release to warehouse date: december 29, 2021.This lot met all dimensional criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.H3, h6: a product investigation was completed: visual analysis of the returned sample revealed that the drill bit was observed with signs of worn from the fluted tip.Due to the worn condition it is reasonable to also confirm the will not cut.No other issues were found.The observed condition was identified as an end of life indicator; damage consistent with repeated use and servicing.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.The drawings reflecting the current and manufactured revisions were reviewed.The overall complaint was confirmed as the observed condition would have contributed to the complained issue.Based on the investigation findings, the potential cause is traced to end of life, and it has been determined that no corrective and/or preventative action is required.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.

• Brand Name: 2.5MM DRILL BIT QC 170MM 80MM CALIBRATION
• Type of Device: 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: 18309825
• MDR Text Key: 330275269
• Report Number: 8030965-2023-15571
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 07612334122087
• UDI-Public: 07612334122087
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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
• Device Operator: Health Professional
• Device Catalogue Number: 03.133.103
• Device Lot Number: U392201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2023
• Initial Date FDA Received: 12/12/2023
• Supplement Dates Manufacturer Received: 12/13/2023
• Supplement Dates FDA Received: 12/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/29/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: DRILL BIT Ø2.5 QC L135 CALIBRATION 45; DRILL BIT Ø2.5 QC L170 CALIBRATION 80; DRILL BIT Ø2.5 QC L170 CALIBRATION 80; EXTRACT-PLIERS F/TEN; SYNREAM REAMING ROD ø2.5 LONG L1150; UNK - ELASTIC NAILS: TITANIUM
• Patient Age: 3 YR
• Patient Sex: Male