MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXP A 5.0 TAP; TAP,BONE

Catalog Number 279751005

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/10/2019

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.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

It was reported that on (b)(6) 2019, during a spinal fusion surgery, while the surgeon was tapping the l2 pedicle with the patient presented with sclerotic bone, the expedium 5.0mm tap broke in the pedicle.A universal hardware removal (uhr) set was opened, using the trephines and screw extractors, the surgeon was able to successfully remove the broken tip of the screw from the patient and the tap was fully retrieved.The broken tap tip was successfully retrieved and compared to the tap¿s shaft.All pieces were confirmed by the rn and surgeon in the operating room.There were no fragments generated.Thus, final x-rays were taken to confirm no broken pieces of tap were left behind.There was a surgical delay of 50-60 minutes.The procedure was completed.The patient's status was unknown.Concomitant device reported: unknown screw (part#: unknown, lot#: unknown, quantity: unknown).This report is for one (1) exp a 5.0 tap.This is report 1 of 1 for (b)(4).

• Brand Name: EXP A 5.0 TAP
• Type of Device: TAP,BONE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 9558924
• MDR Text Key: 176629098
• Report Number: 1526439-2020-00209
• Device Sequence Number: 1
• Product Code: HWX
• UDI-Device Identifier: 10705034358789
• UDI-Public: (01)10705034358789
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 279751005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2019
• 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