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	Detachment of Device or Device Component (2907)
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
Please note corrections to section d9/h3, the device was lost and could not be returned.The reported event could be confirmed, since the product was visible missing on the returned hoffmann lrf construct.The inspection revealed the following: on the foot ring (left side, in the front), we were able to locate one missing nut from one of the four telescopic strut.The threaded bolt shows no deformation or damage.Furthermore, it is visible at the foot ring, that a nut was attached, as the foot ring is slightly discolored at this spot were the nut was.Based on this, it can only by that the nut didn't get tightened enough.A review of the device history was not possible because the lot number was not communicated.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.Based on investigation, the root cause was attributed to a use related issue.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
The following event was reported by the stryker rep: "the hoffmann lrf frame was put on the patient on (b)(6)21 for an ankle fusion procedure to protect the internal hardware.Patient notified the surgeon on (b)(6)-22 complaining of a loud 'pop' or a loose 'clicking sound.Frame was removed on the following day (b)(6)-22.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: 13419620
• Report Number: 0008031020-2022-00029
• Device Sequence Number: 17312431
• 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): 04/21/2022

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: UNKNOWN
• Was Device Available for Evaluation?: No
• 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: 03/25/2022
• Initial Report FDA Received Date: 02/01/2022
• Supplement Report FDA Received Date: 04/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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