MAUDE Adverse Event Report: STRYKER GMBH SUPERELASTIC IMPLANT X FUSE STANDARD / ANGLE 0; PIN, FIXATION, SMOOTH

Model Number	AXF-S0
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device discarded.
Event or Problem Description
Customer reported the following: "description of the facts: broken implant.Observed clinical consequences: implant change".
Event or Problem Description
Customer reported the following: "description of the facts: broken implant; observed clinical consequences: implant change".
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.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.

• Brand Name: SUPERELASTIC IMPLANT X FUSE STANDARD / ANGLE 0
• Common Device Name: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10586135
• Report Number: 0008031020-2020-02264
• Device Sequence Number: 19618966
• Product Code: HTY
• UDI-Device Identifier: 07613252258476
• UDI-Public: 07613252258476
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K070598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2020

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: 06/30/2024
• Device Model Number: AXF-S0
• Device Catalogue Number: AXFS0
• Device Lot Number: D40554
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/03/2020
• Supplement Date Received by Manufacturer: 11/05/2020
• Initial Report FDA Received Date: 09/25/2020
• Supplement Report FDA Received Date: 12/01/2020
• 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: Required Intervention