MAUDE Adverse Event Report: SYNTHES GMBH CANNULATED STARDRIVE SCRWDRVR SHAFT FOR 3.0MM HCS T8; SCREWDRIVER

Catalog Number	03.226.004
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2024, the item had a broke tip.This was noticed during loan kit inspection by the loan kit technician.No further details are available.This report involves one cannulated stardrive scrwdrvr shaft for 3.0mm hcs t8 this is report 1 of 1 for (b)(4).
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: d9: complainant part is not expected to be returned for manufacturer review/investigation.E1 initial reporter state: (b)(6).E3: reporter is a j&j employee.The product was not returned to depuy synthes; however, photos were provided for review.The photo investigation revealed that '03.226.004, scrdriver shaft can t8 w/colour-marking has broken at the tip.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the 2scrdriver shaft cann t8 w/colour-marking would contribute to the complained device issue.Based on the investigation findings, the screw driver shaft has broken because of unintended force, and 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 complaint condition.As part of depuy synthes 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.Device history review (dhr): part: 03.226.004, lot no: 2204607, release to warehouse date: 11 dec, 2006, manufacturing site: werk selzach, supplier: (b)(4).A manufacturing record evaluation was performed for the finished article lot and no non-conformance's were identified.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 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 reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission the the, depuy synthes, ot 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, h4, h6: the product was returned to depuy synthes for evaluation.Visual inspection of the returned device found that a fragment of the tip was broken.Broken fragment was not returned for analysis.The observed condition of the device was consistent with a component failure that was caused by exposure to unintended forces like improper handling, excessive force during use, or accidental impact.A dimensional inspection was unable to be performed due to the post-manufacturing damage.A functional test was unable to be performed due to the post-manufacturing damage.The overall complaint was confirmed as the observed condition of the scrdriver shaft cann t8 w/colour-marking would contribute to the complained device issue.Based on the investigation findings, the potential cause is traced to a component failure, and 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 depuy synthes 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.Device history review (dhr): part:03.226.004.Lot no:2204607.Release to warehouse date:11 dec, 2006.Manufacturing site: werk selzach.Supplier: synthes bettlach gmbh.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, follow-up medwatch will be filed as appropriate.

• Brand Name: CANNULATED STARDRIVE SCRWDRVR SHAFT FOR 3.0MM HCS T8
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2425 ; SZ 2425
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 19709181
• Report Number: 8030965-2024-08380
• Device Sequence Number: 3090178
• Product Code: HXX
• UDI-Device Identifier: 07611819194304
• UDI-Public: (01)07611819194304(11)061211(10)2204607
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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

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: 03.226.004
• Device Lot Number: 2204607
• 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: 06/11/2024
• Supplement Date Received by Manufacturer: 08/01/2024
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2006
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown