MAUDE Adverse Event Report: SYNTHES GMBH DRIVE ADAPTOR WITH QC FOR 5.0MM SCHANZ SCREWS; DRIVER, SURGICAL, PIN

Catalog Number	393.103
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2023, while inspecting the instruments after going through the decontamination process, it was noticed that several instruments were damaged.The handle with quick coupling, small was worn.The plastic on the handle was cracked.The drive adaptor qc for 5.0 schanz screws is a quick connect for shanz pins.Where the quick connect goes into the drill, it is worn and unable to go into the drill.The 5.0mm flexible shaft was worn.The tip of the reamer shaft has prongs on it, and the prongs were bent and unable to hold the reamer head in place.Another 5.0mm flexible shaft was damaged.The 5.0mm flexible shaft 620mm was worn.It was a long rear shaft, and the tip of the reamers shaft has prongs on it, and the prongs were bent and unable to hold the reamer head in place.It is unknown when the damage occurred to these items.There was no patient involvement.This report involves one drive adaptor with qc for 5.0mm schanz screws.This is report 2 of 4 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.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.E3: reporter is a j&j employee.H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or 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.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.H3, h4, h6: the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the shaft coupling of the adapt f/seldrill-schanzscr ø5 presents a worn appearance, consistent with normal and repetitive use over a long period of time consistent as an end of life indicator for the device.The device exhibits damage consistent with repeated use.The lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use, the device must be properly inspected prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedure a dimensional inspection was performed for the adapt f/seldrill-schanzscr ø5 and met specifications.A functional test was unable to performed as the mating device was not returned.The complaint condition was not able to be replicated.The overall complaint was not confirmed as the observed condition of the drive adaptor qc for 5.0 schanz screws would not contribute 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 complaint condition and hence the root cause cannot be determined.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Device history review (dhr): part # 393.103, synthes lot # ft00297, supplier lot # ft00297, release to warehouse date: 03 may 2017, supplier: (b)(4), no ncr's were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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.

• Brand Name: DRIVE ADAPTOR WITH QC FOR 5.0MM SCHANZ SCREWS
• Common Device Name: DRIVER, SURGICAL, PIN
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18427723
• Report Number: 8030965-2024-00058
• Device Sequence Number: 12784642
• Product Code: GFC
• UDI-Device Identifier: 10886982199010
• UDI-Public: (01)10886982199010
• 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,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: 393.103
• Device Lot Number: FT00297
• 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: 12/11/2023
• Supplement Date Received by Manufacturer: 01/24/2024
• Initial Report FDA Received Date: 01/02/2024
• Supplement Report FDA Received Date: 02/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2017
• 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