MAUDE Adverse Event Report: SYNTHES GMBH RATCHETING SCREWDRIVER HANDLE

Catalog Number 311.023

Device Problems Electrical /Electronic Property Problem (1198); Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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.H10 additional narrative: e3: reporter is a j&j sales representative.H3, h4, h6 service and repair evaluation: the customer reported that the top of 311.023, ratcheting screwdriver handle slider handle is stuck.It is unable to be pushed to forward or reverse setting.The repair technician reported that the device had switch screw damaged, switch is not moving, cosmetic test failed, rusted leaf spring and unable to test does device operate smoothly.Damaged component is the reason for repair.The cause of the issue is unknown.The following parts were replaced: ratcheting screwdriver handle, switch, leaf spring, and ball.The item was repaired per the inspection sheet, passed synthes final inspection on 01-february-2024 and will be returned to the customer upon completion of the service and repair process.Attached service record router completed through operation 30.Finalized service record will be archived in tungsten document management system.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.H4, h6 part number: 311.023 lot number: t157324 manufacturing site: tuttlingen release to warehouse date: 18-jun-2014 a review of the device history records was performed for the finished device lot number, 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, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the ratcheting screwdriver handle slider handle is stuck.It is unable to be pushed to forward or reverse setting.The issue was observed during pre-op there was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.It was reported that there was no further information regarding the issue.All available information has been disclosed.No further information was provided.This report is for one (1) ratcheting screwdriver handle this is report 1 of 1 for complaint (b)(4).

• Brand Name: RATCHETING SCREWDRIVER HANDLE
• Type of Device: SCREWDRIVER
• 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: 18761109
• MDR Text Key: 336050736
• Report Number: 8030965-2024-02771
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• 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
• Device Operator: Health Professional
• Device Catalogue Number: 311.023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1