MAUDE Adverse Event Report: STRYKER GMBH SONICANCHOR KIT 2.5X10 MM / FORCE FIBRE #2 / C-7; PIN, FIXATION, SMOOTH

Catalog Number 1910-1273S

Device Problem Difficult to Insert (1316)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/23/2019

Event Type  malfunction  

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

Event Description

Sonic anchor (2) failed to fixate.New implants were used with successful fixation.Slight delay in completion of the procedure (5 minutes) and extra holes were drilled to accommodate new implants.

Manufacturer Narrative

The reported event could not be confirmed.More detailed information about the complaint event such as the storage conditions (temperature mainly) for instance must be available in order to determine the root cause of the complaint event.The device inspection revealed the following: the device received is completely melted.Therefore, further evaluation of the returned device was not possible.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.

Event Description

Sonic anchor (2) failed to fixate.New implants were used with successful fixation.Slight delay in completion of the procedure (5 minutes) and extra holes were drilled to accommodate new implants.

• Brand Name: SONICANCHOR KIT 2.5X10 MM / FORCE FIBRE #2 / C-7
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9345733
• MDR Text Key: 193317360
• Report Number: 0008031020-2019-01866
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 07613327096149
• UDI-Public: 07613327096149
• Combination Product (y/n): N
• PMA/PMN Number: K143063
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/04/2020
• Device Catalogue Number: 1910-1273S
• Device Lot Number: 1000371493
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2019
• Date Manufacturer Received: 01/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR