MAUDE Adverse Event Report: STRYKER GMBH DISTAL LATERAL FIBULA PLATE, 3 HOLE, STERILE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number	40-20903S
Medical Device Problem Codes	Material Fragmentation (1261); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "orif was performed for left distal fibula fracture (primary surgery date is unknown).During the bariatric fibula explanting surgery on (b)(6) 2024, something like metal shavings came out while removing the bone surrounding the screw head." no further information has been provided.
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Additional Manufacturer Narrative
Correction - please refer to d2a, d2b, g1 manufacturing site for devices, h6 device code.The reported event could not be confirmed during the inspection performed.The device inspection revealed the following: the identification of the returned plate was confirmed based on the catalog # and lot # marked.Multiple scratches were observed on the implant's surface and on the holes.The first ones occurred most probably during the implantation and explantation.The later are most probably a direct result of screw insertion.Four holes indicate possible over torque, being highly worn out and partially deformed.It is also likely that the screws were inserted with an angulation outside of the range advised (-15° to 15°).However, despite the damage observed, there is no clear indication of material fragmentation from the plate.Pictures taken during the explantation were received for inspection and confirm the observations made during the device's inspection.As a reminder, the operative technique clearly states that: "during bone screw insertion in an oblong hole, the surgeon should rely on tactile feedback to prevent excessive torque which may result in thread / bone stripping, screw damage / pull through, or screwdriver damage.Proper observation of bone quality, screw size and instrumentation can help determine the appropriate insertion torque during insertion and final tightening of the screw in the plate.When the screw is fully seated during final tightening, an increase of resistance indicates sufficient screw fixation.¿ the instructions for use clearly state that: ¿ when engaging a screwdriver blade within a screw head, the blade must be fully seated within the head of the screw.Placement of all screws requires the use of a dedicated drill guide to ensure proper screw placement.If a drill guide is not used, the plate may be damaged, and the screw may not lock into the plate.¿ excessive tightening of the variax¿ foot locking screw may lead to titanium particle generation.Particles must be removed to prevent potential contamination causing inflammation.¿ the angle of the inserted variax¿ foot locking screw must not exceed 15°".Based on investigation, the root cause was attributed to an user related issue.The failure was most probably caused by over torque applied during the locking screws insertion, possibly with an unadvised angulation.Nonetheless, as aforementioned, there is no indication of material fragmentation from the plate.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 more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "orif was performed for left distal fibula fracture (primary surgery date is unknown).During the bariatric fibula explanting surgery on (b)(6) 2024, something like metal shavings came out while removing the bone surrounding the screw head." no further information has been provided.

• Brand Name: DISTAL LATERAL FIBULA PLATE, 3 HOLE, STERILE
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; postfach; freiburg D-791 11; GM D-79111
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18883892
• Report Number: 0008031020-2024-00118
• Device Sequence Number: 3088914
• Product Code: KTT
• UDI-Device Identifier: 04546540604613
• UDI-Public: 04546540604613
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K081284
• 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): 05/15/2024
• 2 Devices were Involved in the Event: 1 2

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: 40-20903S
• Device Lot Number: 1000497926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/15/2024
• Supplement Date Received by Manufacturer: 04/18/2024
• Initial Report FDA Received Date: 03/12/2024
• Supplement Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose