MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN SCREWDRIVERS

Device Problem Device-Device Incompatibility (2919)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/09/2022

Event Type  Injury  

Manufacturer Narrative

Additional narrative: 510k: this report is for an unknown screwdriver/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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.

Event Description

Device report from depuy synthes reports an event in (b)(6) as follows: it was reported that during a procedure on (b)(6) 2022 two (2) out of four (4) screws could not be removed and had to be drilled laboriously.It was not possible to fit the screwdriver into those two screws.There was about ninety (90) minutes of surgical delay due to the reported event.The procedure was successfully completed.This report is for one (1) unknown screwdriver.This is report 3 of 4 for complaint (b)(4).

• Brand Name: UNKNOWN SCREWDRIVERS
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 8472871282
• MDR Report Key: 14876480
• MDR Text Key: 295058506
• Report Number: 1526439-2022-00970
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2022
• Initial Date FDA Received: 06/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: EXPEDIUM METAL REMOVAL SI & DI; MIS SINGLE INNER SETSCW; MIS SINGLE INNER SETSCW; MIS SINGLE INNER SETSCW; MIS TI CFX FEN POLY 6X45; MMSI ROD PREBENT, 5.5 X45MM, T; MMSI ROD PREBENT, 5.5 X45MM, T
• Patient Outcome(s): Required Intervention