MAUDE Adverse Event Report: STRYKER GMBH HOOK/TRIANGLE BLADE KIT; ARTHROSCOPE

Catalog Number	2056-1
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported, packaging was not sealed.
Additional Manufacturer Narrative
The reported event that hook/triangle blade kit was alleged of 'packaging not sealed' could not be confirmed, since the returned device is conforming to specifications and fully functional.Based on investigation, the root cause was attributed to be user related.The visual inspection confirmed that returned device does not present external wrapping.However, this is normal as these devices are manufactured without external wrapping.Therefore, this case is closed as a non-issue.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
It was reported, packaging was not sealed.

• Brand Name: HOOK/TRIANGLE BLADE KIT
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8053056
• Report Number: 0008031020-2018-00968
• Device Sequence Number: 1953092
• Product Code: HRX
• UDI-Device Identifier: 07613327364286
• UDI-Public: 07613327364286
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K922391
• 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): 01/03/2019

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 Expiration Date: 05/21/2021
• Device Catalogue Number: 2056-1
• Device Lot Number: 01410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2018
• Initial Date Received by Manufacturer: 10/12/2018
• Supplement Date Received by Manufacturer: 12/06/2018
• Initial Report FDA Received Date: 11/08/2018
• Supplement Report FDA Received Date: 01/03/2019
• 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