MAUDE Adverse Event Report: SYNTHES GMBH DEPTH GAUGE F/SCR Ø2+2.4 MEAS-RANGE UP-T; GAUGE, DEPTH

Catalog Number 319.005

Device Problem Device-Device Incompatibility (2919)

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

Event Date 03/28/2023

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.H10 additional narrative: 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.No visible cosmetic issues or damage were detected upon visual inspection.However, during the handling and testing of the sliding device's mechanism, it became evident that the mechanism was excessively rigid and stiff.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the [depth gauge f/scr ø2+2.4 meas-range up-t] would contribute to the complained device issue.  based on the investigation findings, 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 reported 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.H3, h4, h6: device history record (dhr) review conducted: part# 319.005.Lot # l065979.Manufacturing site: werk hägendorf.Supplier: na.Release to warehouse date: 03 jan 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.

Event Description

Device report from depuy synthes reports an event in colombia as follows: it was reported that a depth gauge 2.0/2.4 was too rigid, preventing the sliding of the same and therefore the correct use of it, causing discomfort in the specialist.This report is for one (1) depth gauge f/scr ø2+2.4 meas-range up-t.This is report 1 of 1 for complaint (b)(4).

• Brand Name: DEPTH GAUGE F/SCR Ø2+2.4 MEAS-RANGE UP-T
• Type of Device: GAUGE, DEPTH
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES HAEGENDORF GMBH; im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 18067736
• MDR Text Key: 327316835
• Report Number: 8030965-2023-13905
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 07611819083608
• UDI-Public: (01)07611819083608
• 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: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 319.005
• Device Lot Number: L065979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2017
• 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