MAUDE Adverse Event Report: STRYKER / HOWMEDICA OSTEONICS CORP STRYKER SCREW DRIVER BIT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/25/2022

Event Type  Injury  

Event Description

During a left reverse shoulder arthroplasty, while implanting a screw in the humeral head (in the glenosphier) the tip of the screw driver head broke off the screw driver.This was a new screw driver opened for the case.Decision to leave it in place was made.Fda safety report id#:(b)(4).

• Brand Name: STRYKER SCREW DRIVER BIT
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER / HOWMEDICA OSTEONICS CORP
• MDR Report Key: 13543152
• MDR Text Key: 285756809
• Report Number: MW5107493
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/11/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/15/2022
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 118 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White