MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL TWISTR REAMER (6-12MM); CANNULATED SURGICAL DRILL, SINGLE-USE

Model Number 232000

Device Problems Break (1069); Use of Device Problem (1670)

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

Event Type  malfunction  

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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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.Udi: (b)(4).Investigation summary: the complaint device was received and evaluated.Upon visual inspection, it was found that the device's shaft is broken from the base of the device's handle.A manufacturing record evaluation was performed for the finished device (b)(4) number, and no non-conformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.According with the visual inspection result, this complaint can be confirmed.The possible root cause for this issue can be attributed 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, however, this cannot be conclusively determined.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.

Event Description

It was reported by a healthcare professional in the netherlands that during an anterior cruciate ligament reconstruction procedure on an unknown date, it was observed that the twistr reamer (6-12mm) device ¿almost¿ broke at the proximal end where it was mounted to the powertool.During in-house engineering evaluation, it was determined that upon visual inspection, it was found that the device's shaft wa broken from the base of the device's handle.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.

• Brand Name: TWISTR REAMER (6-12MM)
• Type of Device: CANNULATED SURGICAL DRILL, SINGLE-USE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; 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: 15625230
• MDR Text Key: 304625559
• Report Number: 1221934-2022-03141
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10886705025626
• UDI-Public: 10886705025626
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 232000
• Device Catalogue Number: 232000
• Device Lot Number: A2203005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1