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

Model Number	5463-34-500
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: MISCELLANEOUS JOINT INSTRUMENTS : CEMENT DELIVERY DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9623513
• Report Number: 1818910-2020-02720
• Device Sequence Number: 16695507
• Product Code: KIH
• UDI-Device Identifier: 10603295174646
• UDI-Public: 10603295174646
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/21/2020

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: 5463-34-500
• Device Catalogue Number: 546334500
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 01/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1