MAUDE Adverse Event Report: STRYKER GMBH TOETAC XPRESS SMALL HAMMERTOE IMPLANT; SCREW, FIXATION, BONE

Model Number	HT-00001
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	06/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device is not available; device remains implanted in patient.
Event or Problem Description
As reported: the doctor was using a toe tac implant.Implant had a hard time ¿snapping¿ in.We decided to re-drill the hole but found that one of the three prongs had broken off of the implant and got stuck in the drill hole.We were unable to get it out and used the implant as it was.We left the k wire in for stability.
Event or Problem Description
As reported: the doctor was using a toe tac implant.Implant had a hard time ¿snapping¿ in.We decided to re-drill the hole but found that one of the three prongs had broken off of the implant and got stuck in the drill hole.We were unable to get it out and used the implant as it was.We left the k wire in for stability.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was 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: TOETAC XPRESS SMALL HAMMERTOE IMPLANT
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10290890
• Report Number: 0008031020-2020-01931
• Device Sequence Number: 1072024
• Product Code: HWC
• UDI-Device Identifier: 07613327356366
• UDI-Public: 07613327356366
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K150443
• 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): 10/09/2020

1 Device was Involved in the Event

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 Model Number: HT-00001
• Device Catalogue Number: HT-00001
• Device Lot Number: 01486
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/23/2020
• Supplement Date Received by Manufacturer: 09/15/2020
• Initial Report FDA Received Date: 07/17/2020
• Supplement Report FDA Received Date: 10/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1