MAUDE Adverse Event Report: STRYKER GMBH PLATE ANCHORAGE LISFRANC / MEDIUM - RIGHT; PLATE, FIXATION, BONE

Catalog Number	PLP30172
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/07/2018
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 that surgeon was performing an orif mid foot arthrodesis procedure - right side and was attempting to implant a 3.5 achorage screw, and the screw went through the hole in the plate and proceeded to go all the way through the plate out the back side.Surgeon removed plate and screw and went back in with a new plate and screws and completed the case succesfully and with no delay or adverse consequence to the patient.
Event or Problem Description
It was reported that surgeon was performing an orif mid foot arthrodesis procedure - right side and was attempting to implant a 3.5 achorage screw, and the screw went through the hole in the plate and proceeded to go all the way through the plate out the back side.Surgeon removed plate and screw and went back in with a new plate and screws and completed the case succesfully and with no delay or adverse consequence to the patient.
Additional Manufacturer Narrative
This device is concomitant and did not contribute to the reported failure.Therefore, this complaint is closed without further investigation.If any additional information is provided indicating otherwise the record will be reopened and the investigation will be reworked.

• Brand Name: PLATE ANCHORAGE LISFRANC / MEDIUM - RIGHT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7827323
• Report Number: 0008031020-2018-00577
• Device Sequence Number: 16563837
• Product Code: HRS
• UDI-Device Identifier: 07613252260837
• UDI-Public: 07613252260837
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 11/15/2018

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: PLP30172
• Device Lot Number: ZP2063
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/07/2018
• Supplement Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 08/29/2018
• Supplement Report FDA Received Date: 11/15/2018
• 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