MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL RATCHET HANDLE; SURGICAL SCREWDRIVER, REUSABLE

Model Number	254847
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).The lot number was unknown.Investigation summary: according to the information provided, it was reported that ratchet handle was broken.The complaint device was received and evaluated.Visual observations reveal that the collar tri-lobe pusher component was detached and separated from the device.In addition, the device was dull, and appears worn.The functional testing was not performed due to damage on the device.The complaint can be confirmed.The possible root cause for the reported failure can be attributed to the collar tri-lobe pusher was unscrewed from the cap retaining or can be associated to normal field wear.However, this cannot be conclusive.Given that lot number was not provided, a manufacturing record evaluation (mre) review cannot be performed.If the lot number becomes available, the mre review will be performed.At this point in time, no corrective action is required and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.
Event or Problem Description
It was reported by the affiliate in (b)(6) that during an arthroscopy procedure on (b)(6) 2020, it was observed that the ratchet handle device was broken.During in-house engineering evaluation, it was determined that the collar tri-lobe pusher component was detached and separated from the device.Another like device was used to complete the procedure with a five minute delay.There were no fragments generated.There were no adverse patient consequences reported.No additional information was provided.

• Brand Name: RATCHET HANDLE
• Common Device Name: SURGICAL SCREWDRIVER, REUSABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• MDR Report Key: 11147035
• Report Number: 1221934-2021-00081
• Device Sequence Number: 3920232
• Product Code: LXH
• UDI-Device Identifier: 10886705027699
• UDI-Public: 10886705027699
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/08/2021

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 Model Number: 254847
• Device Catalogue Number: 254847
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2021
• Initial Report FDA Received Date: 01/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1