MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US BIOSTOP G RESTR TRIAL 14MM; MISCELLANEOUS JOINT INSTRUMENTS : CEMENT DELIVERY DEVICES

Model Number 5463-34-500

Device Problem Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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.

Event Description

The metal restrictor that was used for the placement of the biostop plug has accidentally been left inside the femoral canal.

• Brand Name: BIOSTOP G RESTR TRIAL 14MM
• Type of Device: MISCELLANEOUS JOINT INSTRUMENTS : CEMENT DELIVERY DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9623513
• MDR Text Key: 184936876
• Report Number: 1818910-2020-02720
• Device Sequence Number: 1
• Product Code: KIH
• UDI-Device Identifier: 10603295174646
• UDI-Public: 10603295174646
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 01/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5463-34-500
• Device Catalogue Number: 546334500
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/21/2020
• 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
• Patient Age: 90 YR