MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LARGE SHIELDED CALCAR PLANER; HIP INSTRUMENTS : REAMERS

Model Number L94010

Device Problems Failure to Cut (2587); Naturally Worn (2988)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/08/2021

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.

Event Description

Screw driver damaged, not gripping, edges with visible signs of wear calcar reamers not cutting, visible signs of wear was surgery delayed due to the reported event? yes, if yes, number of minutes: 10.Action taken when event occurred? another step of instruments opened.Was procedure successfully completed? yes.

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.

Event Description

Screw driver damaged, not gripping, edges with visible signs of wear calcar reamers not cutting, visible signs of wear was surgery delayed due to the reported event? yes, if yes, number of minutes: 10.Action taken when event occurred? another step of instruments opened.Was procedure successfully completed? yes.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device was received for examination, therefore the reported event could not be confirmed.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: LARGE SHIELDED CALCAR PLANER
• Type of Device: HIP INSTRUMENTS : REAMERS
• 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 ; 1210 ward av; west chester, PA 19380 ; 6107428552
• MDR Report Key: 13054361
• MDR Text Key: 285459805
• Report Number: 1818910-2021-28642
• Device Sequence Number: 1
• Product Code: LYS
• UDI-Device Identifier: 10603295325192
• UDI-Public: 10603295325192
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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
• Device Operator: Health Professional
• Device Model Number: L94010
• Device Catalogue Number: L94010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2021
• Initial Date FDA Received: 12/21/2021
• Supplement Dates Manufacturer Received: 01/13/2022
• Supplement Dates FDA Received: 01/16/2022
• 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