MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX FULL THREAD 3.5MM / L16MM; PLATE, FIXATION, BONE

Model Number	614616
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Impaired Healing (2378)
Date of Event	04/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned, and no other evidence was provided.A device inspection was not possible since the affected device was not returned and no other evidence was provided.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.More information, the affected device as well as patient¿s medical records must be available in order to determine the exact root cause of the failure.If any additional information is provided, the investigation will be reassessed.Device disposition unknown.
Event or Problem Description
As reported"; after fracture the patient was treated with a clavicle plate on (b)(6) 2020, which had to be replaced on (b)(6) 2020 because a screw had loosened.(this revision was reported separately) a lysis seam around the screws was diagnosed, which caused a loosening.Phone call with the patient on (b)(6) 2020 revealed the following clarifications: the patient initially reached out to stryker because after the surgery there was no visible bone healing.Patient also indicated that at the end of (b)(6) she had another ct scan which revealed well bone healing.Additional information received on 11/30/2020 with product details which confirmed the devices to be stryker screws for the primary and the revision surgery.
Additional Manufacturer Narrative
Correction: refer to d6a & d6b.
Event or Problem Description
As reported"; after fracture the patient was treated with a clavicle plate on (b)(6) 2020, which had to be replaced on (b)(6) 2020 because a screw had loosened.(this revision was reported separately) a lysis seam around the screws was diagnosed, which caused a loosening.Phone call with the patient on (b)(6) 2020 revealed the following clarifications: the patient initially reached out to stryker because after the surgery there was no visible bone healing.Patient also indicated that at the end of july she had another ct scan which revealed well bone healing.Additional information received on (b)(6) 2020 with product details which confirmed the devices to be stryker screws for the primary and the revision surgery.

• Brand Name: LOCKING SCREW VARIAX FULL THREAD 3.5MM / L16MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11069900
• Report Number: 0008031020-2020-02602
• Device Sequence Number: 3260192
• Product Code: HRS
• UDI-Device Identifier: 07613154969760
• UDI-Public: 07613154969760
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K101056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2021

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: Lay User/Patient
• Device Model Number: 614616
• Device Catalogue Number: 614616
• Device Lot Number: D58943
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/30/2020
• Supplement Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 12/23/2020
• Supplement Report FDA Received Date: 01/05/2021
• 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