MAUDE Adverse Event Report: STRYKER GMBH VOLAR SMARTLOCK DISTAL RADIUS PLATE, NARROW, RIGHT,SHORT, 9 HOLES; PLATE, FIXATION, BONE

Catalog Number 54-25384S

Device Problems Device Dislodged or Dislocated (2923); Separation Problem (4043)

Patient Problems Failure of Implant (1924); Injury (2348)

Event Date 02/21/2020

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device discarded.

Event Description

The customer reported that a distal locking screw backed out of the 9 holes volar smartlock dr plate (narr) 5h.Revision surgery.

Event Description

The customer reported that a distal locking screw backed out of the 9 holes volar smartlock dr plate (narr) 5h.Revision surgery.

Manufacturer Narrative

Correction: refer to h6 device code.The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.If any additional information is provided, the investigation will be reassessed.

• Brand Name: VOLAR SMARTLOCK DISTAL RADIUS PLATE, NARROW, RIGHT,SHORT, 9 HOLES
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9837470
• MDR Text Key: 191828958
• Report Number: 0008031020-2020-00719
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K040022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/24/2024
• Device Catalogue Number: 54-25384S
• Device Lot Number: 1000343712
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/21/2020
• Initial Date FDA Received: 03/16/2020
• Supplement Dates Manufacturer Received: 05/07/2020
• Supplement Dates FDA Received: 06/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention