MAUDE Adverse Event Report: SYNTHES GMBH DEPTH GAUGE FOR SMALL SCREWS

Catalog Number	319.09
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while inspecting the instruments after going through the decontamination process, it was noticed that there were several instruments that were either damaged or had issues and were in need of replacement.The instruments that were damaged, they were not sure when the damage occurred.Some of the instruments that had issues have things like rust in the cannulation areas and or the graphics case was bent beyond repair and/or was flaking off the coating on the case.There was no patient involvement for any of these items.1.Product # 03.043.028, lot # 22234101, quantity 1.This item is an impact for the ans system in the pin that is welded has come apart, so the pin is floating free.2.Product # 319.09, lot # 8774p99, quantity 1.This item is a depth gauge, and there is rust on part of the depth gauge they will not come off.3.Product # 03.010.495, lot # pe05189, quantity 1.This item is a reduction tool and is cannulated with rust on the inside of the cannulation.4.Product # 60.527.015, lot # unknown, quantity 1.This item is a screw rack and is bent with the lid, unable to be locked and was disposed out by the facility.5.Product # 60.333.200, lot # unknown, quantity 3.These three items are graphic cases, and the coding is coming off of them.These three items were disposed up by the facility.6.Product # 03.333.601, lot # unknown, quantity 1.This item is a ratcheting handle and it had rust on it.Because it was unable to be used it was disposed up by the facility.7.Product # 03.333.304, lot # 271069, quantity 2.Both of these items have the same lot number and they are both cannulated t 15 drivers that are stripped.8.Product # 03.168.014, lot # 3l03530, quantity 1.This item is a t 25 driver that is bent.This item is able to be returned.9.Product # 03.045.110, lot # 400708, quantity 1.This item is a monobloc reamer and there is rust approximately 1 inch from the tip in the canal.10.Product # 03.045.130, lot # 400895, quantity 1.This item is a mono block rumor and there is rust.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional narrative: h3, h6: a manufacturing record evaluation was performed for the finished device.Product code: 319.090-us.Lot: 8774p99.It was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 17 january 2024.Manufacturing site: jabil bettlach.The product was returned to depuy synthes for evaluation.Visual inspection of the returned device found that the scale body presents signs of rust over its surface, the reported allegation is confirmed according to the document cleaning and sterilization instructions, the following precautions should be taken: all devices must be thoroughly cleaned and inspected prior to sterilization.Long, narrow lumens, blind holes, moving and intricate parts require particular attention during cleaning and inspection.During cleaning, only use cleaning agents that are labelled for use on medical devices and in accordance with the manufacturer¿s instructions (e.G.Temperature, contact time, and rinse time).Cleaning agents with a used dilution ph of within 7¿9.5 are recommended.Highly alkaline conditions (ph >11) can damage components/devices, such as aluminum materials.Do not use saline, environmental disinfection (including chlorine solutions) or surgical antiseptics (such as iodine- or chlorhexidine-containing products).Do not use a cleaning aid that can damage the surface of instruments such as steel wool, abrasive cleaners or wire brushes.Additionally it was found that the nut that hold the scale body was missing, this condition may occur during the cleaning/sterilization process, particularly when the components are assembled or disassembled.As these procedures are often repeated, there is an increased risk of components going missing.However, without concrete evidence or further information, it is not possible to determine a root cause.Furthermore it was observed that the tip of the gauge was bent upwards.The observed condition of the device was consistent with a component failure that was caused by exposure to unintended forces.A functional test was not performed since it was not applicable to the complaint condition.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 for small screws would have contributed 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 j&j medtech orthopaedics 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.The drawings reflecting the current and manufactured revisions were reviewed.

• Brand Name: DEPTH GAUGE FOR SMALL SCREWS
• Common Device Name: DEPTH GAUGE
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 24122501
• Report Number: 8030965-2026-00677
• Device Sequence Number: 20318650
• Product Code: HTJ
• UDI-Device Identifier: 10886982189998
• UDI-Public: (01)10886982189998(10)8774P99
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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: 319.09
• Device Lot Number: 8774P99
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2024
• 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