MAUDE Adverse Event Report: SYNTHES GMBH 2.8MM DRILL BIT/QC/165MM

Catalog Number 310.284

Device Problem Material Integrity Problem (2978)

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

Event Date 12/01/2022

Event Type  malfunction  

Event Description

Device report from colombia reports an event as follows: it was reported that during a procedure on (b)(6) 2022, two drill bits had to be changed out due to defects.Procedure was completed with no delay.There was no patient consequence.Upon manufacturer investigation, it was determined that one drill bit had the cutting edges of the fluted tip blunt and worn.This report is for a 2.8mm drill bit/qc/165mm.This is report 2 of 2 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.H10 additional narrative: h3, h6: a manufacturing record evaluation was performed for the finished device.Product code: 310.284 lot: 93p3909 it was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: march 3, 2021.Manufacturing site: jabil bettlach.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 lcp drill bit ø2.8 w/stop l165 2flute f/ had the cutting edges of the fluted tip blunt and worn.The observed condition was consistent as an end of life indicator for the device.No other issues were identified.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 blunt and worn condition of lcp drill bit ø2.8 w/stop l165 2flute f/ 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.Drawing/specifications reviewed: drill bit 2-flute dx.X with stop ring (current and manufactured) 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: 2.8MM DRILL BIT/QC/165MM
• Type of Device: DRILL BIT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17689685
• MDR Text Key: 322714876
• Report Number: 8030965-2023-11163
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 07611819245891
• UDI-Public: (01)07611819245891
• 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

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: 310.284
• Device Lot Number: 93P3909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2023
• Initial Date FDA Received: 09/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2021
• 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 Ø2.8 W/SCAL L200/100 3FLUTE F/