MAUDE Adverse Event Report: SYNTHES GMBH 4.3MM DRILL BIT QC/221MM

Catalog Number 310.430

Device Problem Material Integrity Problem (2978)

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

Event Date 10/25/2023

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.H3, h6: a product investigation was conducted.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 the lcp drill bit ø4.3 w/stop l221 2flute f/ was found stripped from the fluted tip and the stop ring is missing.No other issues were observed.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.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures.A dimensional inspection was unable to be performed due to post manufacturing damage.A functional test was not performed as it is not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the lcp drill bit ø4.3 w/stop l221 2flute f/ 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.H3, h4, h6: device history record (dhr) review conducted: product code: : 310.430.Lot number : l077888.Release to warehouse date : 29.Jul.2016.Expiration date : na.Supplier: na.Manufacturing site: werk bettlach.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.

Event Description

Device report from depuy synthes reports an event in belgium as follows: it was reported that devices were defective.No patient consequences reported.During manufacturer's investigation of the returned device it was identified that the lcp drill bit ø4.3 w/stop l221 2flute f/ was stripped from the fluted tip and the stop ring is missing.This report is for one (1) 4.3mm drill bit qc/221mm this is report 1 of 2 for complaint (b)(4).

• Brand Name: 4.3MM DRILL BIT QC/221MM
• 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 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 18567566
• MDR Text Key: 333539410
• Report Number: 8030965-2024-01263
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 07611819246591
• UDI-Public: (01)07611819246591
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 310.430
• Device Lot Number: L077888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2016
• 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