MAUDE Adverse Event Report: STRYKER GMBH NON LOCKING SCREW ANCHORAGE Ø3.0MM / L24MM; PLATE, FIXATION, BONE

Catalog Number	PLSS3024
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/21/2018
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.Most of the screw implanted; screw head disposed by hospital.
Event or Problem Description
Primary procedure, right foot.It was reported that went implanting a screw into the anchorage i plate, the head of the screw broke off.After brief deliberation, surgeon decided there would be less risk leaving the screw in than trying to remove the remainder of the screw.Surgeon utilized a different hole in the plate.A surgical delay of approximately 1 minute was reported.

• Brand Name: NON LOCKING SCREW ANCHORAGE Ø3.0MM / L24MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7883152
• Report Number: 0008031020-2018-00608
• Device Sequence Number: 11444649
• Product Code: HRS
• UDI-Device Identifier: 07613252262763
• UDI-Public: 07613252262763
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 09/17/2018

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: Health Professional
• Device Catalogue Number: PLSS3024
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2018
• Initial Report FDA Received Date: 09/17/2018
• 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: 67 YR