MAUDE Adverse Event Report: STRYKER GMBH CONNECTING NUT - SHORT HOFFMANN LRF M8 X 6MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	4933-1-010
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
The following event was reported by the stryker rep: "the hoffmann lrf frame was put on the patient on (b)(6) 2021 for an ankle fusion procedure to protect the internal hardware.Patient notified the surgeon on (b)(6) 2022 complaining of a loud 'pop' or a loose 'clicking sound.Frame was removed on the following day (b)(6) 2022.Every wire broke and nuts loosened up.The surgeon mentioned the patient was not walking on it throughout the few weeks it was on.".
Additional Manufacturer Narrative
This device is concomitant and did not contribute to the reported failure.Therefore, this complaint is closed without further investigation.If any additional information is provided indicating otherwise the record will be reopened and the investigation will be reworked.
Event or Problem Description
The following event was reported by the stryker rep: "the hoffmann lrf frame was put on the patient on (b)(6) 2021 for an ankle fusion procedure to protect the internal hardware.Patient notified the surgeon on (b)(6) 2022 complaining of a loud 'pop' or a loose 'clicking sound.Frame was removed on the following day (b)(6) 2022.Every wire broke and nuts loosened up.The surgeon mentioned the patient was not walking on it throughout the few weeks it was on.".

• Brand Name: CONNECTING NUT - SHORT HOFFMANN LRF M8 X 6MM
• 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: 13424189
• Report Number: 0008031020-2022-00033
• Device Sequence Number: 17141806
• Product Code: KTT
• UDI-Device Identifier: 07613252610304
• UDI-Public: 07613252610304
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K113327
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2022

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: 4933-1-010
• Device Catalogue Number: 49331010
• Device Lot Number: G33399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2022
• Supplement Date Received by Manufacturer: 02/16/2022
• Initial Report FDA Received Date: 02/02/2022
• Supplement Report FDA Received Date: 03/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male