MAUDE Adverse Event Report: STRYKER GMBH OLIVE WIRE, S.S, DRILL POINT RINGFIX Ø1.8MM X 400MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	451-3004
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/05/2022
Type of Reportable Event	Serious Injury
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
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
The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure.The device inspection revealed the following: on the upper ring (right side, in the front), we were able to locate one broken wire, the wire broke right at the wire bolt.The wire bolt and nut show no deformation or damage.Further investigation together with engineering departments (mechanical / biomechanics) has shown that: fatigue failure was identified on the wires.The cracks were initiated on the side of the wires experiencing tension stresses and at the level of the marks left by the teeth of the wire bolts.It is not possible to assess if this was a low cycle or a high cycle fatigue failure, but the type of rupture and the rupture locations let us think that the frame was submitted to repetitive compression loads such as occurring during walking.On the other hand, only 2 wires were mounted per ring in opposition to the op- technique which recommends 3 fixation points (wire) for such a frame.We conclude therefore that the rupture of the wire was due to cyclic overloading.Dimensional inspection: we checked whether the specified diameter of 1.8mm is correct, we can confirm that it is a 1.8mm wire.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.The failure was caused by cyclic overloading.If more information is provided, the case will be reassessed.

• Brand Name: OLIVE WIRE, S.S, DRILL POINT RINGFIX Ø1.8MM X 400MM
• 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: 13423870
• Report Number: 0008031020-2022-00031
• Device Sequence Number: 3953412
• Product Code: KTT
• UDI-Device Identifier: 00886385012292
• UDI-Public: 00886385012292
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K071394
• 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): 03/25/2022

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: 451-3004
• Device Catalogue Number: 4513004
• Device Lot Number: UNKNOWN
• 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: 03/17/2022
• Initial Report FDA Received Date: 02/02/2022
• Supplement Report FDA Received Date: 03/25/2022
• 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