MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL INTRFX ADV -MOD HEX DRIVER; SURGICAL SCREWDRIVER, REUSABLE

Model Number	254836
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).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.Investigation summary: according to the information provided, it was reported that the tip of the hex driver was twisted.The complaint device was received and evaluated.Visual observations revealed that the distal portion of the hex driver was twisted and bent.The complaint can be confirmed.Besides, the device not presented another visual damages.The laser lines in the device are intact.The possible root cause for the reported failure can be associated with excess torque being applied and since this is a reusable device, this failure has possibly occurred after using it in this manner for many procedures.However; this cannot be conclusive determined.A manufacturing record evaluation was performed for the finished device lot/serial number (b)(4), and no non-conformances were identified.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.Udi: (b)(4).
Event or Problem Description
It was reported by the sales rep via phone that during an acl procedure the ratchet handle did not work properly as the ratchet function is not working anymore.The manual function had to be used.It was noticed as well that the tip of the hex driver was twisted.Same device was used to complete the procedure.No patient consequences or surgical delay reported.These devices are available to be returned for evaluation.

• Brand Name: INTRFX ADV -MOD HEX DRIVER
• Common Device Name: SURGICAL SCREWDRIVER, REUSABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10062950
• Report Number: 1221934-2020-01391
• Device Sequence Number: 19732971
• Product Code: LXH
• UDI-Device Identifier: 10886705026296
• UDI-Public: 10886705026296
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Type of Report: Initial
• Report Date (Section B): 05/14/2020

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: 254836
• Device Catalogue Number: 254836
• Device Lot Number: 1801001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/14/2020
• Initial Report FDA Received Date: 05/15/2020
• Patient Sequence Number: 1