MAUDE Adverse Event Report: SYNTHES GMBH DEPTH GAUGE FOR 3.5MM CORTEX SCREWS

Catalog Number	319.091
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The following product issues were reported to have occurred on an unknown date: depth gauge for 3.5mm cortex screws (x 3) - hook is broken from usage in pelvis.Ratchet wrench-11mm width across flats (x 3) - ratchet doesn¿t work.2.4/2.7 volt(tm) scr rack 6-90 2 high 1/3 width alum frame (x 2) - racks are faded from wash and soap.1.6mm/0.8mm double drill guide (x 2) - guide is bent.2.0mm/1.1mm double drill guide (x 2) - guide is bent.2.7mm compression/distraction post/for va-locking hole x 6- threads are stripped.2.8mm guide wire/ 300mm length fluted tip (x 6)- threads stripped.2.7mm volt(tm) condylar plate 6h/58mm (x 1) - plate did not lock with locking screw.2.7mm volt(tm) condylar plate 10h/95mm (x 1) plate did not lock with locking screw.15.5mm monobloc flexible reamer - long (x 2) - reamers are dull.Periosteal elevator 14mm straight blade-round edge (x 3)- rust on elevator.There was no patient involvement; issues were noted in sterile processing.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: h3, h6: product was not returned.Based on the information available, it has been determined that no corrective and 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.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 FOR 3.5MM CORTEX SCREWS
• Common Device Name: DEPTH GAUGE
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 22748421
• Report Number: 8030965-2025-08156
• Device Sequence Number: 15842374
• Product Code: HTJ
• UDI-Device Identifier: 10886982190000
• UDI-Public: (01)10886982190000
• Combination Product (Y/N): N
• 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,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
• Operator of Device: Health Professional
• Device Catalogue Number: 319.091
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2025
• Supplement Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 09/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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