MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK DRILL/DRIVER SHAFT

Catalog Number UNK DRILL/DRIVER SHAFT

Device Problems Break (1069); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/03/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 while trying to remove the drill bit from driver shaft the drill bit broke off inside driver shaft.The driver shaft is now useless as a new drill bit cannot be inserted.No surgical delay.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned, thus the reported event could not be confirmed.The investigation could not verify or identify any product contribution to the reported event with the information provided.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Territory 238 reports while trying to remove the drill bit from the drive shaft the drill bit broke off inside the driver shaft.Follow up information found the shaft was deemed to be deficient by spd staff.The device associated with this report was not returned.From the provided information it appears the drive shaft may have seized or jammed and the drill bit broke when trying to remove from the shaft.From the provided information it appears there is no allegation against the unknown drill bit.However, with no instrument returned and no more information, no root cause can be determined for this specific instrument.A search of the complaint database could not be conducted as the part and lot number was not provided.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the inability to identify root cause, the need for corrective action was not indicated.Complaints will be monitored under post market surveillance sep 419.

• Brand Name: UNK DRILL/DRIVER SHAFT
• Type of Device: DRILL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9244201
• MDR Text Key: 172574515
• Report Number: 1818910-2019-112489
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK DRILL/DRIVER SHAFT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1