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

Catalog Number	54-25674
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7891486
• Report Number: 0008031020-2018-00617
• Device Sequence Number: 169275
• Product Code: HRS
• UDI-Device Identifier: 07613252614463
• UDI-Public: 07613252614463
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K133974
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 54-25674
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/22/2018
• Supplement Date Received by Manufacturer: 10/31/2018
• Initial Report FDA Received Date: 09/19/2018
• Supplement Report FDA Received Date: 11/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 32 YR