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

Catalog Number	49603000
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
As reported: "we received a complaint about the hoffmann2 micro lengthener via surgeon/nurses at the (b)(6).The case happened on (b)(6) 2024 for a metacarpal lengthening case.The surgeon reported that the distractor didn't work as expected.As the micro-lengthener was used to distract the bone, the pins moved inside the clamp and resulted in an unexpected outcome." the patient had to come back an additional three times to have the device adjusted ((b)(4) visits in total).The first 4 i believe would have been under anaesthetic 2 general and 2 local as there was pins being inserted and significant adjustment being made.The final time they were not under anaesthetic as just pins were being removed.The revisions took place because the pins would become lose within the clamp and thus be ineffective.
Additional Manufacturer Narrative
The complaint couldn't be confirmed, since the device was not returned for evaluation and no other evidence were provided.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required currently.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.More detailed information about the complaint event must be available 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.
Event or Problem Description
As reported: "we received a complaint about the hoffmann2 micro lengthener via surgeon/nurses at the (b)(6).The case happened on (b)(6) 2024 for a metacarpal lengthening case.The surgeon reported that the distractor didn't work as expected.As the micro-lengthener was used to distract the bone, the pins moved inside the clamp and resulted in an unexpected outcome." the patient had to come back an additional three times to have the device adjusted (5 visits in total).The first 4 i believe would have been under anaesthetic 2 general and 2 local as there was pins being inserted and significant adjustment being made.The final time they were not under anaesthetic as just pins were being removed.The revisions took place because the pins would become lose within the clamp and thus be ineffective.

• 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
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19413675
• Report Number: 0008031020-2024-00230
• Device Sequence Number: 16947290
• Product Code: KTT
• UDI-Device Identifier: 04546540492791
• UDI-Public: 04546540492791
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K052037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2024

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 Catalogue Number: 49603000
• Device Lot Number: L04306
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/01/2024
• Supplement Date Received by Manufacturer: 06/18/2024
• Initial Report FDA Received Date: 05/29/2024
• Supplement Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/27/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown