MAUDE Adverse Event Report: SYNTHES GMBH 2.0MM STARDRIVE SCRWDRVR BLADE W/SPRG HLDG SLV SHRT/66MM MQC; SCREWDRIVER

Catalog Number	314.676
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2026
Type of Reportable Event	Malfunction
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.H11 additional narrative:.
Event or Problem Description
It was reported that on (b)(6) 2026, the patient underwent an unknown surgery with the product in question.During the surgery, the veterinarian attempted to grasp the screw with the screwdriver in question but was unable to do so properly.Even when grasped, the screw was held at an angle to the screwdriver.The veterinarian adjusted the screw by hand to secure it, and the surgery was completed without incident.The surgery was completed successfully with no surgical delay.No further information is 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: added: b5.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
Additional information received: it was reported that this screwdriver in question was used to grip the demo screw.The screw holder could hold the screw head, however there was a gap between the star driver and the gripped star screw, which would lead the screw to move left and right after gripping.

• Brand Name: 2.0MM STARDRIVE SCRWDRVR BLADE W/SPRG HLDG SLV SHRT/66MM MQC
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HAEGENDORF; im bifang 6; haegendorf CO ; SZ
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 25002128
• Report Number: 8030965-2026-03856
• Device Sequence Number: 9885110
• Product Code: HXX
• UDI-Device Identifier: 10887587037646
• UDI-Public: (01)10887587037646(10)70411P7
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,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: 314.676
• Device Lot Number: 70411P7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/10/2026
• Supplement Date Received by Manufacturer: 04/28/2026; 05/22/2026; 06/12/2026
• Initial Report FDA Received Date: 04/27/2026
• Supplement Report FDA Received Date: 04/29/2026; 05/25/2026; 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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