MAUDE Adverse Event Report: SYNTHES GMBH DEPTH GAUGE FOR 1.3MM/1.5MM AND 2.0MM SCREWS; GAUGE, DEPTH

Catalog Number	03.130.250
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2023
Type of Reportable Event	Malfunction
Additional 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: d9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: part# 03.130.250.Lot # 1l85249.Manufacturing site: (b)(4).Supplier: na.Release to warehouse date: 07 nov 2018.Expiration date: na.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified the product was not returned to depuy synthes, however photos were provided for review.The photo investigation did not revealed the reported jammed/seized condition for depth gauge f/scr ø1.3 - 2 meas-range.Review of provided photo shows the depth guage, but without having actual device for evaluation the functional allegation of jammed/seized remains unconfirmed and cause remains undetermined.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was unconfirmed as the observed condition of the depth gauge f/scr ø1.3 - 2 meas-range - would not contribute to the complained device issue.Based on the investigation findings, potential cause not established 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.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 or Problem Description
Device report from synthes reports an event in new zealand as follows: it was reported that on (b)(6) 2023, the surgeon was using the va hand set consigned to the hospital, the screw could not be measured because the depth gauge was jammed.Another depth gauge from a different set was used.The procedure was completed successfully.There were no patient consequence.This report involves one (1) depth gauge for 1.3mm/1.5mm and 2.0mm screws.This is report 1 of 1 for (b)(4).

• Brand Name: DEPTH GAUGE FOR 1.3MM/1.5MM AND 2.0MM SCREWS
• Common Device Name: GAUGE, DEPTH
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BALSTHAL (CH); dornacherstrasse 20; balsthal 4710 ; SZ 4710
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18327318
• Report Number: 8030965-2023-15716
• Device Sequence Number: 18022688
• Product Code: HTJ
• UDI-Device Identifier: 07611819690691
• UDI-Public: 07611819690691
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• 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
• Operator of Device: Health Professional
• Device Catalogue Number: 03.130.250
• Device Lot Number: 1L85249
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2023
• Initial Report FDA Received Date: 12/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown