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

Catalog Number	254847
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	01/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Udi: (b)(4).Investigation summary: the complaint device was received and inspected.The complaint can be confirmed.The tri-lobe collar was received detached from the rest of the handle.The retaining cap had been unscrewed from the collar.The device was forwarded to the manufacturer for further investigation into the failure.A capa was initiated to further investigate this complaint.The supplier investigated under a supplier corrective action request.Visual inspection of the device components revealed no adhesive residue was observed on the joint to the naked eye, likely an error in production.The investigation revealed that the supplier lacks the call-outs for adhesives on the print, however procedures and work instructions provide the controls necessary to catch the non-conformance issue of no adhesive being applied.As the non-conformance has not exceeded the acceptable limit, and there was no trend detected, correction of the nonconformance only is required at this time.This non-conformance has been found to be an isolated and one-off event.No further action is warranted at this time.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 sales rep via phone that during an acl reconstruction procedure, it was observed that the customer's ratchet handle quick connect pulled straight off the device.The sales rep stated that this occurred while the device was being loaded and happened prior to use on the patient.The case was completed with a hex driver with no patient harm, but a two minute delay to obtain the new device.During in-house engineering evaluation, it was determined that the tri-lobe collar was received detached from the rest of the handle and the retaining cap had been unscrewed from the collar.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: RATCHET HANDLE
• Common Device Name: SURGICAL SCREWDRIVER, REUSABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9370676
• Report Number: 1221934-2019-59760
• Device Sequence Number: 16716076
• Product Code: LXH
• UDI-Device Identifier: 10886705027699
• UDI-Public: 10886705027699
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/21/2019

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: 254847
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/21/2019
• Initial Report FDA Received Date: 11/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1