MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL RETROREAMER (6-12MM)

Catalog Number	232000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	08/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.H11 additional narrative: e3: reporter is a j&j sales representative.H4: the device manufacture date is currently unavailable.Investigation summary the product was returned to j&j medtech orthopaedics for evaluation.J&j medtech orthopaedics then conducted visual inspection of the device received.The complaint device was evaluated, visual inspection reveled that the shaft was broken near the handle.The overall complaint was confirmed as the observed condition of the retroreamer (6-12mm) would have contributed to the complained device issue.Based on the investigation findings, the potential cause can be traced to procedural variables, such handling of the device or product interaction during procedure, the device may become stuck due to a hard bone surface at the moment of drilling, therefore, the shaft broke.As per instructions for use (ifu), use instructions are provided.It has been determined that no corrective and/or preventative action is required.As part of j&j medtech orthopaedics 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 lot a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.
Event or Problem Description
It was reported from japan that during an anterior cruciate ligament (acl) reconstruction of the knee it was observed that the shaft and handle of the retroreamer (6-12mm) device broke.During in-house engineering evaluation it was determined that the shaft was broken near the handle.It was reported that during the surgery, twister guides were set, and retrograde reamers were set to 10 millimeters (mm) for drilling.The surgeon removed only the guide arm and proceeded to freehand a few mm until the line was visible in the joint.Since the reamer came out in front of the guide installation position, the reamer was inserted and removed at the very edge of the joint surface about three times in order to bring the position where the reamer comes out toward the back.When the surgeon turned the reamer to pull the 10 mm reverse blade out, the shaft and handle completely broke off.The sockets were not dug at all.The 10-mm blade had locked up with the blade out in the joint, so the surgeon tried to close the blade from inside and outside the joint.As a result, the reamer was pulled out by reversing the through-hole with the blade closed from 10 mm.It was reported that bones were shaved extra.It was reported that the reconstructive surgery itself was performed by re-tensioning the tendon with an extended button, bringing out a new retrograde reamer, and re-drilling the hole in approximately the same position.It was reported that there was a 60-minute surgical delay.There were no adverse patient consequences reported although the surgeon commented that it was expected to increase in postoperative swelling and pain due to prolonged operation time.No additional information was provided.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H11: additional narrative: h4: the device manufacture date was reported as unknown on the initial report.Please note that the date of manufacture has been updated accordingly.

• Brand Name: RETROREAMER (6-12MM)
• Common Device Name: REAMER
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 20465947
• Report Number: 1221934-2024-03701
• Device Sequence Number: 7254940
• Product Code: HTO
• UDI-Device Identifier: 10886705025626
• UDI-Public: (01)10886705025626(10)A2309005(17)260831
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• 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 Expiration Date: 08/31/2026
• Device Catalogue Number: 232000
• Device Lot Number: A2309005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2024
• Supplement Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown