MAUDE Adverse Event Report: STRYKER GMBH LENGTHENER ASSEMBLY HOFFMANN II MICRO; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	4960-3-000
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of the investigation any additional information will be communicated in a supplemental report.
Event or Problem Description
It was reported the hoffmann micro lengthener assembly implanted / installed on (b)(6) 2021 for 4th metatarsal osteotomy & lengthening.Surgeon reported this week that distal clamp on monotube fixator had become loose, and was causing a shift into plantar flexion of the patient's 4th metatarsal.To date, nothing uncorrectable has occurred per discussion with the surgeon and patient.Patient was directed to stop at-home lengthening procedures until the exchange could be made, and to my understanding, has been directed to resume as of the installation of new device.
Additional Manufacturer Narrative
D9 / h3 updated to indicate device was not returned.The reported event could not be confirmed since the device was not returned for evaluation and no other evidence was shared.A device inspection was not possible since the affected device was not returned and no other evidence was shared for evaluation.The batch record could not be reviewed because the affected device was not returned, and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.H3 other text : device disposition is unknown.
Event or Problem Description
It was reported the hoffmann micro lengthener assembly implanted / installed on (b)(6)2021 for 4th metatarsal osteotomy & lengthening.Surgeon reported this week that distal clamp on monotube fixator had become loose, and was causing a shift into plantar flexion of the patient's 4th metatarsal.To date, nothing uncorrectable has occurred per discussion with the surgeon and patient.Patient was directed to stop at-home lengthening procedures until the exchange could be made, and to my understanding, has been directed to resume as of the installation of new device.

• Brand Name: LENGTHENER ASSEMBLY HOFFMANN II MICRO
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 12304847
• Report Number: 0008031020-2021-00348
• Device Sequence Number: 17027135
• Product Code: KTT
• UDI-Device Identifier: 04546540492791
• UDI-Public: 04546540492791
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K052037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2021

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 4960-3-000
• Device Catalogue Number: 49603000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/15/2021
• Supplement Date Received by Manufacturer: 09/08/2021
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 09/22/2021
• 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: Required Intervention