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

Catalog Number	1910-1273S
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9345733
• Report Number: 0008031020-2019-01866
• Device Sequence Number: 2739755
• Product Code: HTY
• UDI-Device Identifier: 07613327096149
• UDI-Public: 07613327096149
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K143063
• 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): 01/08/2020

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 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
• Initial Date Received by Manufacturer: 10/23/2019
• Supplement Date Received by Manufacturer: 01/03/2020
• Initial Report FDA Received Date: 11/19/2019
• Supplement Report FDA Received Date: 01/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR