MAUDE Adverse Event Report: SYNTHES GMBH SCRDRIVER-HEX-SMALL 2.5 W/GROOVE; SCREWDRIVER

Catalog Number	314.070
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2025
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 medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that the patient was admitted for fracture of the diaphysis of the 2 bones of the left forearm.During the surgery, the handle of the screwdriver broke while the plate was being screwed into the bone.The handle is made of wood (debris in the wound).
Event or Problem Description
Additional information received: a.Was there a surgical delay in relation to the reported event? -yes, just a few minutes to rinse the wound thoroughly to evacuate any small debris that may fall.B.Was/were there any adverse consequence/s that affected the patient because of the reported event? -no c.Were there pieces broken off from the instrument? if yes, did it break into 2 or more pieces? -yes, the instrument broke into more than 2 pieces d.Were the broken fragments retained in the patient? (yes or no): -no visible fragments remained in the patient e.Was other medical intervention required? if yes, please specify details.-no 7.Was the surgery completed successfully? (yes or no): -yes.
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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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.H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.
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.H3, h6: the product was returned to j&j medtech orthopaedics for evaluation.The j&j medtech orthopaedics team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that scrdriver-hex-small 2.5 w/groove was broken from the handle.The broken fragments were returned for evaluation.Also, color changes were noted along the handle surface.The attached letter for sustaining engineering documents that the phenolic material, not this specific device, has been tested through numerous reprocessing cycles and slight color changes were noted but no signs of severe degradation such as bleeding or erosion were found.The returned instrument is over 14 years old and the slight fading and breakage noted on the phenolic handle would be expected for a device that has gone through numerous reprocessing cycles.A dimensional inspection for the scrdriver-hex-small 2.5 w/groove was not performed due to post manufacturing damage.He observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the scrdriver-hex-small 2.5 w/groove would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition.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.Device history lot part:314.070 lot:3624240 manufacturing site: werk hagendorf supplier: na release to warehouse date: 09 dec 2010 expiration date: na a manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SCRDRIVER-HEX-SMALL 2.5 W/GROOVE
• 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: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 21335064
• Report Number: 8030965-2025-01409
• Device Sequence Number: 15591059
• Product Code: HXX
• UDI-Device Identifier: 07611819019829
• UDI-Public: (01)07611819019829(10)3624240
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Initial Reporter Occupation: Pharmacist
• 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: 314.070
• Device Lot Number: 3624240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2025
• Supplement Date Received by Manufacturer: 02/17/2025; 03/04/2025; 03/06/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 02/27/2025; 03/05/2025; 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/09/2010
• 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