MAUDE Adverse Event Report: STRYKER GMBH PLATE ANCHORAGE BASAL OSTEOTOMY / WEDGE 0MM; PLATE, FIXATION, BONE

Catalog Number	PLP50230
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/13/2018
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
The following event was reported: the head of the locking screw diameter 3.5 mm and length 2 cm went through the anchorage plate catalog# plp50230.Precautionary measure and actions taken by a change of devices.
Additional Manufacturer Narrative
This device is concomitant and did not contribute to the reported failure.Therefore, this report can be disregarded.If any additional information is provided indicating otherwise, a supplemental report will be provided.
Event or Problem Description
The following event was reported: the head of the locking screw diameter 3.5 mm and length 2 cm went through the anchorage plate catalog# plp50230.Precautionary measure and actions taken by a change of devices.

• Brand Name: PLATE ANCHORAGE BASAL OSTEOTOMY / WEDGE 0MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8256881
• Report Number: 0008031020-2019-00031
• Device Sequence Number: 19256730
• Product Code: HRS
• UDI-Device Identifier: 07613252261032
• UDI-Public: 07613252261032
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2019

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: PLP50230
• Device Lot Number: F48660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2019
• Initial Date Received by Manufacturer: 12/21/2018
• Supplement Date Received by Manufacturer: 02/21/2019
• Initial Report FDA Received Date: 01/17/2019
• Supplement Report FDA Received Date: 03/20/2019
• 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
• Patient Weight: 64