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

Catalog Number 319.006

Device Problem Material Deformation (2976)

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

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.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 sales representative.H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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

It was reported on an unknown date that some items were removed from a modular mini-fragment and needed to be replaced.2.0 and 2.4/2.7 bending irons are bleeding a rust-looking substance from the lettering printed.The drill guide cannot separate the inserts to disassemble because the threaded tip won¿t slide over the insert.The depth gauge tip is bent.The 2.7-module side is broken.There was no patient involvement, and no adverse events occurred.This report is for one (1)depth gauge f/scr ø2+2.4 meas-range up-t this is report 1 of 2 for complaint.

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.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 depth gauge f/scr ø2+2.4 meas-range up-t was found with the needle deformed/bent.The protection sleeve was not received.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 deformed/bent condition of depth gauge f/scr ø2+2.4 meas-range up-t 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 the following source controlled drawings reflecting the current and manufactured revisions were reviewed: - depth gauge for 2.0 / 2.4mm screws 319_006_susa rev.N (current) / rev.E (manufactured).H4, h6 part # 319.006, synthes lot # 6525316, supplier lot #na, release to warehouse date: 17 nov 2010 , manufactured by: synthes jennersville.No non conformance reports were generated during production.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: DEPTH GAUGE F/SCR Ø2+2.4 MEAS-RANGE UP-T
• Type of Device: DEPTH GAUGE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17785362
• MDR Text Key: 323877137
• Report Number: 8030965-2023-11868
• Device Sequence Number: 1
• Product Code: HTJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 319.006
• Device Lot Number: 6525316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/05/2023
• Initial Date FDA Received: 09/20/2023
• Supplement Dates Manufacturer Received: 10/09/2023
• Supplement Dates FDA Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2020
• 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: 2.7MM LCP(TM) MODULE CASE; 2.7MM UNIVERSAL DRILL GUIDE; BEND-PIN F/LCP-PL 2; BEND-PIN F/LCP-PL 2; BEND-PIN F/LCP-PL 2.4+2.7; BEND-PIN F/LCP-PL 2.4+2.7