MAUDE Adverse Event Report: STRYKER GMBH CROSS PLATE? MTP, RIGHT ANCHORAGE; PLATE, FIXATION, BONE

Model Number	PLP14342
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/09/2020
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
Plate failed to accept locking screws.Prolonged the case by 5 minutes to switch to different plate.
Additional Manufacturer Narrative
Due to the current covid-19 pandemic it was not possible to inspect the product as the access to the facility is restricted.The investigation will be reassessed as soon as restriction is lifted.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 complaint report will be updated.
Event or Problem Description
Plate failed to accept locking screws.Prolonged the case by 5 minutes to switch to different plate.

• Brand Name: CROSS PLATE? MTP, RIGHT ANCHORAGE
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9748401
• Report Number: 0008031020-2020-00515
• Device Sequence Number: 727568
• Product Code: HRS
• UDI-Device Identifier: 07613252260608
• UDI-Public: 07613252260608
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K083447
• 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): 05/21/2020

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 Model Number: PLP14342
• Device Catalogue Number: PLP14342
• Device Lot Number: D25248
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2020
• Initial Date Received by Manufacturer: 01/28/2020
• Supplement Date Received by Manufacturer: 05/19/2020
• Initial Report FDA Received Date: 02/24/2020
• Supplement Report FDA Received Date: 05/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1