MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC 1818910 UNKNOWN SHOULDER LOCKING SCREW

Catalog Number UNK SHOULDER LOCKING SCREW

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/20/2018

Event Type  malfunction  

Manufacturer Narrative

(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

Reverse total shoulder replacement, dr.(b)(6), (b)(6) hospital, (b)(6) 2018.During use on a patient, it was found that one of the four prongs on the locking screw driver main body had broken off and when the surgeon was implanting the first (inferior) locking screw, the screw driver broke the head off that particular screw.In this situation, we had to break the rest of the head off the screw to bury it as we were unable to remove it.A replacement screw driver has since been sent up, however, there is a need for and the surgeon has requested to have a spare screw driver on consignment in any case in the future.No ae to patient: 10 minutes delay in surgery.Patient id: (b)(6).

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Product complaint #: (b)(4).Investigation summary : the reported event cannot be confirmed due to the product not being returned.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: UNKNOWN SHOULDER LOCKING SCREW
• Type of Device: SHOULDER LOCKING SCREW
• 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: 7665023
• MDR Text Key: 113626481
• Report Number: 1818910-2018-63833
• Device Sequence Number: 1
• Product Code: MJT
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER LOCKING SCREW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR