MAUDE Adverse Event Report: STRYKER GMBH SONICANCHOR KIT 2.5X10 MM / FORCE FIBRE #2-0 / C-2; PIN, FIXATION, SMOOTH

Catalog Number	1910-1271S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device remains implanted.
Event or Problem Description
It was reported that during a surgical procedure for tendon repair, an expired device was implanted in the patient.The issue was noticed upon creation of the billing sheet.Surgeon feels there is no patient harm and has no plans to surgically address the issue.Device was not hospital owned or hospital controlled.Rep reported that x-rays, medical records, and further information are not available due to hospital policy.
Additional Manufacturer Narrative
The reported event that sonicanchor kit 2.5x10 mm/force fibre #2-0 / c-2 was alleged of 'sterile period expired' could be confirmed, since the device was implanted on the (b)(6) 2018, and the end of sterilization of the reported lot was the (b)(6) 2016.Based on investigation, the root cause was attributed to be user related.The failure was caused by inattention of the sales representative to the expiration date of the device.Following this information, the representative will be informed and actions will be taken locally in order to avoid such events in the future.A review of the device history for the reported lot did not indicate any abnormalities.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.
Event or Problem Description
It was reported that during a surgical procedure for tendon repair, an expired device was implanted in the patient.The issue was noticed upon creation of the billing sheet.Surgeon feels there is no patient harm and has no plans to surgically address the issue.Device was not hospital owned or hospital controlled.Rep reported that x-rays, medical records, and further information are not available due to hospital policy.

• Brand Name: SONICANCHOR KIT 2.5X10 MM / FORCE FIBRE #2-0 / C-2
• Common Device Name: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7792705
• Report Number: 0009610622-2018-01026
• Device Sequence Number: 11146807
• Product Code: HTY
• UDI-Device Identifier: 07613327096170
• UDI-Public: 07613327096170
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K143063
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2018

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: Lay User/Patient
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: 1910-1271S
• Device Lot Number: 1000266714
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/20/2018
• Supplement Date Received by Manufacturer: 10/11/2018
• Initial Report FDA Received Date: 08/17/2018
• Supplement Report FDA Received Date: 11/08/2018
• 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