MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX 2 T10, FULL THREAD, 3.5MM / L14MM; SCREW, FIXATION, BONE

Catalog Number	657314S
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Failure of Implant (1924); Inflammation (1932); Foreign Body In Patient (2687); Swelling/ Edema (4577)
Date of Event	10/25/2023
Type of Reportable Event	Serious Injury
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 on (b)(6) 2021 the patient had primary surgery and a fibular plate and screws were inserted.The plate and screws were extracted on (b)(6) 2022 due to completed bone union.On (b)(6) 2023 the patient was seen in the outpatient clinic because of the appearance of an inflammatory reaction.The affected area had started to swell a little around january and then the bulge in the affected area grew larger.A metal shard-like substance was removed from the surgical wound through a small incision.
Additional Manufacturer Narrative
Please note the correction to d9/h3.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.Only a part of a ripped off thread was returned.However, it could not be possible to determine if the fragment is from one of the reported screws or from the plate.The fragment does not enable a detailed investigation.The root cause of the reported event could not be determined.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 the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that on (b)(6) 2021.The patient had primary surgery and a fibular plate and screws were inserted.The plate and screws were extracted on (b)(6) 2022 due to completed bone union.On 25 october 2023 the patient was seen in the outpatient clinic because of the appearance of an inflammatory reaction.The affected area had started to swell a little around january and then the bulge in the affected area grew larger.A metal shard-like substance was removed from the surgical wound through a small incision.

• Brand Name: LOCKING SCREW VARIAX 2 T10, FULL THREAD, 3.5MM / L14MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18219248
• Report Number: 0008031020-2023-00409
• Device Sequence Number: 12442827
• Product Code: HWC
• UDI-Device Identifier: 07613327086850
• UDI-Public: 07613327086850
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K132502
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/31/2026
• Device Catalogue Number: 657314S
• Device Lot Number: H24423
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2023
• Supplement Date Received by Manufacturer: 01/04/2024
• Initial Report FDA Received Date: 11/28/2023
• Supplement Report FDA Received Date: 01/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female