MAUDE Adverse Event Report: STRYKER GMBH DISTAL LATERAL FIBULA PLATE, 4 HOLE, STERILE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number	40-20904S
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	02/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device was discarded.
Event or Problem Description
It was reported that when the locking screw was not able to be removed and the head of the screw was broken.Therefore, when the doctor tried to be separated with plate and bone, the screw and plate were removed together and a cortical bone in front broken a little.The patient had no symptoms and the doctor not done additional treatment.In order to bone fusion, the plate and screw of implanted at (b)(6) 2018 was removed.Adverse consequences: a cortical bone in front broken a little.
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.
Event or Problem Description
It was reported that when the locking screw was not able to be removed and the head of the screw was broken.Therefore, when the doctor tried to be separated with plate and bone, the screw and plate were removed together and a cortical bone in front broken a little.The patient had no symptoms and the doctor not done additional treatment.In order to bone fusion, the plate and screw of implanted at (b)(6) 2018 was removed.Adverse consequences: a cortical bone in front broken a little.

• Brand Name: DISTAL LATERAL FIBULA PLATE, 4 HOLE, STERILE
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8392759
• Report Number: 0008031020-2019-00146
• Device Sequence Number: 193327
• Product Code: KTT
• UDI-Device Identifier: 04546540604620
• UDI-Public: 04546540604620
• Combination Product (Y/N): N
• PMA/510(K) Number: K081284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 40-20904S
• Device Lot Number: 1000281462
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/05/2019
• Supplement Date Received by Manufacturer: 03/21/2019
• Initial Report FDA Received Date: 03/05/2019
• Supplement Report FDA Received Date: 04/08/2019
• 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: 62