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

Model Number	1910-1272S
Medical Device Problem Code	Shelf Life Exceeded (1567)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/21/2018
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.Device is implanted.
Event or Problem Description
As reported: "products were 1 day past expiration day.Doctor was notified.Doctor will write down in notes post op, and review patient on a regular basis.".
Event or Problem Description
As reported: "products were 1 day past experiation day.Doctor was notified.Doctor will write down in notes post op, and review patient on a regular basis.".
Additional Manufacturer Narrative
The reported event that sonicanchor kit 2.5x10 mm / force fibre #0 / c-2 was alleged of 'sterile period expired' could be confirmed.Based on investigation, the root cause was attributed to be user related, since it is the responsibility of the medical staff to check the sterility dates of the products that are used on the operative room.As a reminder, the ifu states: ¿ inspection is recommended prior to surgery to determine if implants have been damaged during storage or prior procedures.Ensure that you are familiar with the intended uses, indications/ contraindications, compatibility and correct handling of the implant, which are described in the operative technique manual for the product system.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 #0 / C-2
• Common Device Name: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7441503
• Report Number: 0008031020-2018-00305
• Device Sequence Number: 1007149
• Product Code: HTY
• UDI-Device Identifier: 07613327096163
• UDI-Public: (01)07613327096163
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 06/19/2018

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: 02/20/2018
• Device Model Number: 1910-1272S
• Device Catalogue Number: 1910-1272S
• Device Lot Number: 1000250108
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/22/2018
• Supplement Date Received by Manufacturer: 05/25/2018
• Initial Report FDA Received Date: 04/18/2018
• Supplement Report FDA Received Date: 06/19/2018
• 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: 47 YR