MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH ANATOMIC SHAVER 8MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	287001008
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/01/2024
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: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: initial reporter is a depuysynthes sales representative h3, h4, h6: without a lot number the device history records review could not be completed.Product was not returned.H3, h6: a photo investigation was completed: the photo investigation revealed the shaver had broken into two pieces.The observed condition of the device was consistent with a component failure that may have been caused by exposure to unintended forces.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition would contribute to the complained device issue.Based on the investigation findings, potential cause can be attributed to unintended use error 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.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 intraoperatively, an anatomic shaver broke in the patient¿s disc space while in use.Another set was called and opened, and the procedure was successfully completed with a five to ten (5-10) minute surgical delay.This report is for a disc shaver.This is report 1 of 1 for (b)(4).

• Brand Name: ANATOMIC SHAVER 8MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 19917194
• Report Number: 1526439-2024-02006
• Device Sequence Number: 20733495
• Product Code: LXH
• UDI-Device Identifier: 10705034215617
• UDI-Public: (01)10705034215617
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare 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 Catalogue Number: 287001008
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/12/2024
• Initial Report FDA Received Date: 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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