MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 DLC DEPTH GAUGE; HIP INSTRUMENTS : DRILL GUIDES

Catalog Number 227436000

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2018

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

I was not present for the case.Surgeon said that the depth gauge was not at the correct angle and would not slide correctly.Said that he could not get the proper reading off the depth gauge.Po# has been requested - for no charge replacement.Patient consequence? :no.Is the information being submitted for this complaint all the details that are known/available regarding this event? : yes.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: the instrument associated with this report was not returned.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate. .

• Brand Name: DLC DEPTH GAUGE
• Type of Device: HIP INSTRUMENTS : DRILL GUIDES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0998
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0998
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0998 ; 5743725905
• MDR Report Key: 7778444
• MDR Text Key: 116958798
• Report Number: 1818910-2018-66499
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10603295109198
• UDI-Public: 10603295109198
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/16/2018

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 Catalogue Number: 227436000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/16/2018
• Initial Date FDA Received: 08/13/2018
• Supplement Dates Manufacturer Received: 10/12/2018
• Supplement Dates FDA Received: 10/15/2018
• 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: Reuse
• Patient Sequence Number: 1