MAUDE Adverse Event Report: SYNTHES GMBH HANDLE FOR TORQUE LIMITING ATTACHMENT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	03.110.005
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2024
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.H11 additional narrative: d9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.E1 initial reporter state: western australia e3: reporter is a j&j employee.H3, h4, h6: the product was not returned to depuy synthes, however photos were provided for review.The photo investigation revealed that 03.110.005, handle f/torque limiters 0.4/0.8/1.2nm had broken, and upon visual inspection, the screw is missing.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended force.¿since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the handle f/torque limiters 0.4/0.8/1.2nm would contribute to the complained device issue.Based on the investigation findings, 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.The device lot number is unknown, therefore a¿device history review could not be performed.¿ if the lot/serial number becomes available, the record will be re-assessed.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) 2024, the item was missing the screw.This was identified during loan kit inspection by the loan kit technician.No further details are available.This report involves one handle for torque limiting attachment.This is report 1 of 1 for (b)(4).
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.H11 additional narrative: d9 date device returned to manufacturer.H3, h6: the product was returned to depuy synthes for evaluation.Visual inspection of the returned device found that the screw of the handle was missing, therefore, the reported event can be confirmed.Potential cause cannot be established with available information, and considering the device was found at a loan kit inspection.A dimensional inspection was unable to be performed due to the post-manufacturing damage.A functional test was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the handle f/torque limiters 0.4/0.8/1.2nm would contribute to the complained device issue.Based on the investigation findings, the potential cause cannot be established, 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): a manufacturing record evaluation was performed for the finished device, product code:03.110.005, lot no:2717p59.It was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 30-nov-2022.Manufacturing site:jabil bettlach.Corrected data: d4primary udi number updated.G1 manufacturing site name updated.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: HANDLE FOR TORQUE LIMITING ATTACHMENT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach CO 2544 ; SZ 2544
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 19704787
• Report Number: 8030965-2024-08381
• Device Sequence Number: 3701594
• Product Code: LXH
• UDI-Device Identifier: 07611819955592
• UDI-Public: (01)07611819955592(11)221130(10)2717P59
• 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: 03.110.005
• Device Lot Number: 2717P59
• 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: 07/09/2024
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2022
• 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