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

Model Number	HT-00002
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Inflammation (1932); Injury (2348)
Date of Event	07/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported that: "incision and exploration of 2nd phalanx proximal to middle phalangeal joint was explored.Upon joint exploration implant could not initially be located.Flexor digitorum tendon was incised to explore if implant was floating freely within the joint.Implant was not found still.Upon exploring the middle phalanx implant was found protruding, intact, from middle phalanx with proximal portion of implant exposed.Implant was removed from the middle phalanx using the toe tac driver handle.Flexor digitorum tendon was repaired with sutures.Proximal interphalangeal joint was articulated and stabilized with a 0.045" k-wire and incision was closed with sutures.".
Event or Problem Description
It was reported that: " incision and exploration of 2nd phalanx proximal to middle phalangeal joint was explored.Upon joint exploration implant could not initially be located.Flexor digitorum tendon was incised to explore if implant was floating freely within the joint.Implant was not found still.Upon exploring the middle phalanx implant was found protruding, intact, from middle phalanx with proximal portion of implant exposed.Implant was removed from the middle phalanx using the toe tac driver handle.Flexor digitorum tendon was repaired with sutures.Proximal interphalangeal joint was articulated and stabilized with a 0.045" k-wire and incision was closed with sutures.".
Additional Manufacturer Narrative
Conclusion: 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.Device disposition is unknown.

• Brand Name: TOETAC XPRESS MEDIUM HAMMERTOE IMPLANT
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10434260
• Report Number: 0008031020-2020-02185
• Device Sequence Number: 2814174
• Product Code: HWC
• UDI-Device Identifier: 07613327356359
• UDI-Public: 07613327356359
• 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
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2020

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 Model Number: HT-00002
• Device Catalogue Number: HT-00002
• Device Lot Number: 01471
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/24/2020
• Supplement Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 08/20/2020
• Supplement Report FDA Received Date: 11/10/2020
• 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
• Patient Age: 58 YR
• Patient Weight: 89