MAUDE Adverse Event Report: STRYKER GMBH VOLAR DR PLATE INTERM. LEFT SHORT; PLATE, FIXATION, BONE

Catalog Number 54-25674

Device Problems Loose or Intermittent Connection (1371); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/22/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Primary procedure, right distal radius.As reported: "dr.(b)(6).Was using a 2.4x20 variax2 locking screw and when doing his final tightening the screw would not lock.He was able to keep the screw in place but the locking mechanism was not fully utilized.Neither the patient nor the outcome of the surgery was affected.Rep reported that x-rays, medical records, and further information are not available due to hospital policy.

Manufacturer Narrative

This device is concomitant and did not contribute to the reported failure.If any additional information is provided indicating otherwise the record will be reopened and the investigation will be reworked.

Event Description

Primary procedure, right distal radius.As reported: "dr.(b)(6) was using a 2.4x20 variax2 locking screw and when doing his final tightening the screw would not lock.He was able to keep the screw in place but the locking mechanism was not fully utilized.Neither the patient nor the outcome of the surgery was affected.Rep reported that x-rays, medical records, and further information are not available due to hospital policy.

• Brand Name: VOLAR DR PLATE INTERM. LEFT SHORT
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7891486
• MDR Text Key: 120979909
• Report Number: 0008031020-2018-00617
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07613252614463
• UDI-Public: 07613252614463
• Combination Product (y/n): N
• PMA/PMN Number: K133974
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/29/2018

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: 54-25674
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/22/2018
• Initial Date FDA Received: 09/19/2018
• Supplement Dates Manufacturer Received: 10/31/2018
• Supplement Dates FDA Received: 11/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 32 YR