MAUDE Adverse Event Report: SYNTHES GMBH DOUBLEDRILLGUIDE 1.3/1

Catalog Number 312.133

Device Problems Device-Device Incompatibility (2919); Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Date 10/30/2023

Event Type  malfunction  

Event Description

Device report from synthes reports an event in colombia as follows: it was reported on (b)(6) 2023, that the drill bit 1.1 l75/61 2 arist cutting drill bits twisted specialist non-conforming.Drill bit 1.0 l46/34, broken drill bits, specialist non-conforming guide drill bit 1.3/1.0, guide comes in twisted system by side 1.0, does not pass drill bit 1.0.Prolongation of surgical times this report is for one (1)doubledrillguide 1.3/1 this is report 4 of 4 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: d9: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.E3: reporter is a j&j employee.H3, h4, h6 the product was not returned to depuy synthes, however photo was provided for review.See attachment source file - fw external formato de novedad clínica bolivariana 443368.The photo investigation revealed that the device 312.133, doubledrillguide 1.3/1 one of the guide/sleeve was deformed/bent and functionality issues can not be evaluated through a photo investigation.No further evidence can be observed from the photo to determine the root cause.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the 312.133, doubledrillguide 1.3/1 would contribute to the complained device issue.Based on the investigation findings, and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.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.H4, h6.Part# 312.133.Lot # l494290.Manufacturing site: werk hägendorf.Supplier: na.Release to warehouse date: 18 sep 2017.Expiration date: na.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.

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, 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 1.0 guide was found deformed.The unable to assemble allegation can be attributed to the deformed condition.No other issues were observed.A dimensional inspection was not performed due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to excessive/unintended forces.The overall complaint was confirmed as the observed condition of the double drillguide 1.3/1 [312.133/l494290] would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition.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.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.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: DOUBLEDRILLGUIDE 1.3/1
• Type of Device: GUIDE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18173293
• MDR Text Key: 329220525
• Report Number: 8030965-2023-14595
• Device Sequence Number: 1
• Product Code: FZX
• UDI-Device Identifier: 07611819075061
• UDI-Public: (01)07611819075061
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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

• Date FDA Received: 11/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 312.133
• Device Lot Number: L494290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2017
• 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 Ø1 L46/34 2FLUTE; DRILL BIT Ø1.1 L75/61 2FLUTE; DRILL BIT Ø1.1 L75/61 2FLUTE