MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN HIP INSTRUMENTS

Catalog Number UNK HIP INSTRUMENTS

Device Problems Break (1069); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/10/2018

Event Type  malfunction  

Manufacturer Narrative

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 a drill bit broke off into the bone behind the acetabular cup while drilling prior to placing a screw.The broken bit was inaccessible, without removing the cup.Surgeon opted to leave behind the drill bit in patient vs doing more harm to remove.The bit broke in use during surgery.The surgeon implanted a pinnacle porocoat sector ii shell.The 35mm flex drill bit broke as surgeon was prepping cup for a 6.5 x 35mm bone screw.Given the broken bit in the screw hole, the surgeon opted to place a screw in another hole and leave the broken bit in the patient.I spoke with the dr.And although unhappy about the incident, he felt the best course of action, was to leave it in place.He said the bit was fully surrounded by cancellous bone and showed little potential to migrate.He said removing the cup and attempting to dig the fragment of drill bit out, would have done more harm than good.He informed the patient of the event and will monitor it, going forward.No surgical delay.

Manufacturer Narrative

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: UNKNOWN HIP INSTRUMENTS
• Type of Device: HIP INSTRUMENTS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7572907
• MDR Text Key: 110269429
• Report Number: 1818910-2018-61427
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP INSTRUMENTS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2018
• 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: 61 YR