MAUDE Adverse Event Report: SYNTHES GMBH TORQUE-LIMITING T-HANDLE 7NM; SCREWDRIVER

Catalog Number 321.133

Device Problem Calibration Problem (2890)

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

Event Date 08/31/2023

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: 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, h4, h6: without a lot number the device history records review could not be completed.Product was not returned.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.

Event Description

It was reported that on (b)(6) 2023, during routine incoming inspection of a loaner set it was observed that material torque-limiting t-handle 7nm, sn (b)(6) was found to be out of drawing specification.The drawing specification is 7.0 nm ¿ 8.4 nm.The torque tested high ¿ 8.41 nm.There was no known patient or hospital involvement.The product has been quarantined and is available and is being returned to the repair site.A replacement device has been ordered.No replacement product is required, and no shipping label is required for the product return.There were no patient outcome or consequences.This report is for one (1) torque-limiting t-handle 7nm this is report 1 of 1 for complaint (b)(4).

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 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.

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, h6: a product investigation was conducted.Service and repair evaluation: the customer reported that on (b)(6) 2023, during routine incoming inspection of a loaner set it was observed that material torque-limiting t-handle 7nm, sn (b)(6) was found to be out of drawing specification.The torque tested high.The repair technician reported product not in spec and forwarded to customer service for repair at supplier.The cause of the issue is unknown.The item will be repaired and will be returned to the customer upon completion of the service and repair process.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.H3, h6: device history record (dhr) review conducted: part # 321.133, synthes lot # 6553063, supplier lot # 6553063, release to warehouse date:07 mar 2011, supplier: (b)(4), no ncr's 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: TORQUE-LIMITING T-HANDLE 7NM
• Type of Device: SCREWDRIVER
• 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: 17772624
• MDR Text Key: 323706089
• Report Number: 8030965-2023-11771
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 10705034769110
• UDI-Public: (01)10705034769110
• 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,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
• Device Operator: Health Professional
• Device Catalogue Number: 321.133
• Device Lot Number: 6553063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/31/2023
• Initial Date FDA Received: 09/19/2023
• Supplement Dates Manufacturer Received: 01/22/2024; 03/08/2024
• Supplement Dates FDA Received: 01/24/2024; 03/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2011
• 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