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

Catalog Number UNK HIP INSTRUMENTS

Device Problem Break (1069)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)

Event Date 12/03/2018

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

It was reported that the tip of a drill bit 2.5 mm was broke off in the patients right tibia.Surgeon elected to leave the piece in the tibia since it would do more harm to the patient to retrieve it.There was reportedly only a slight delay as a result of the event.

Manufacturer Narrative

No device or product details were received.Root cause undetermined.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.Product complaint #: (b)(4).Investigation summary: no device or product details were received.Root cause undetermined.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.Device history lot: null.Device history batch: null.Device history review: null.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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
• MDR Report Key: 8266460
• MDR Text Key: 133789578
• Report Number: 1818910-2019-81690
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/26/2018

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: UNK HIP INSTRUMENTS
• Device Lot Number: H698169
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/26/2018
• Initial Date FDA Received: 01/22/2019
• Supplement Dates Manufacturer Received: 02/12/2019
• Supplement Dates FDA Received: 02/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1