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

Catalog Number	1910-1273S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/13/2019
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
It was reported that a device with an expiration date of (b)(6) 2019 was implanted on (b)(6) 2019.
Event or Problem Description
It was reported that a device with an expiration date of 05 january 2019 was implanted on (b)(6) 2019.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was implanted on the (b)(6) 2019, and the end of sterilization of the reported lot was the (b)(6) 2019.Based on investigation, the root cause was attributed to be user related.The failure was caused by inattention of the hcp to the expiration date of the device.Since no adverse consequences were reported on this event after weeks of implentation, no further adverse consequences can be expected.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 the device is returned or if any additional information is provided, the investigation will be reassessed.

• 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: 8409356
• Report Number: 0009610622-2019-00105
• Device Sequence Number: 13821440
• Product Code: HTY
• UDI-Device Identifier: 07613327096149
• UDI-Public: 07613327096149
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K143063
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2019

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: 1910-1273S
• Device Lot Number: 1000288534
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/13/2019
• Supplement Date Received by Manufacturer: 03/28/2019
• Initial Report FDA Received Date: 03/11/2019
• Supplement Report FDA Received Date: 04/18/2019
• 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