MAUDE Adverse Event Report: SYNTHES GMBH RATCHETING SCREWDRIVER HANDLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	311.023
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2022
Type of Reportable Event	Malfunction
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.Additional narrative: additional device product codes: hxx.Reporter is a j&j employee.Part number: 311.023.Lot number: t148942.Manufacturing site: tuttlingen.Release to warehouse date: 28-sep-2017.A review of the device history records was performed for the finished device lot number and a nc was started because the laser marking was incomplete.The necessary actions to ensure the final product quality have been taken and documented in the appropriate quality system.The nc have no impact to the complaint condition.The final quality release criteria were met before this batch was released for distribution.Service and repair evaluation: the customer reported that the top of 311.023, ratcheting screwdriver handle is stuck and did not rachet forward.The repair technician reported that the large ball bearing showed signs of oxidation, screw that holds the inner assembly in place was missing, quick coupling failed to lock attachment, thumb latch failed to work in forward, lock and reverse mode, and device failed to operate smoothly.Missing parts is the reason for repair.The cause of the issue is unknown.The following parts were replaced: ratchet coupling, screws, leaf spring, ball, and spring.The item was repaired per the inspection sheet, passed synthes final inspection on (b)(6) 2022 and will be returned to the customer upon completion of the service and repair process.Finalized service record will be archived.The evaluation was confirmed.The device was deemed serviceable and will be returned to the customer, no design or manufacturing issues were identified therefore it has been determined that no corrective and/or preventative action is proposed.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.
Event or Problem Description
It was reported that on (b)(6) 2022, the top was stuck, and it will not ratchet forward.There were no patient consequences, and no other medical intervention was required.No further information is available.This report involves one ratcheting screwdriver handle.This is report 1 of 1 for (b)(4).

• Brand Name: RATCHETING SCREWDRIVER HANDLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16131289
• Report Number: 8030965-2023-00360
• Device Sequence Number: 7654969
• Product Code: LXH
• UDI-Device Identifier: 10887587035673
• UDI-Public: 10887587035673
• 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

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 Model Number: 311.023
• Device Catalogue Number: 311.023
• Device Lot Number: T148942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2023
• Initial Report FDA Received Date: 01/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2017
• 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