MAUDE Adverse Event Report: STRYKER GMBH FOOT ARCH HOFFMANN LRF 180MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number	49346180
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device disposiiton is unknown.
Event or Problem Description
This pi is for the second revision of patient's foot arch, and hexapod strut issue.As reported: ".We replace that foot arch with a new one and he[patient] breaks that one the following week.Bring him back to office and revise.While revising we notice the pin in the hexapod strut was starting to come out".Rep indicated patient factor: diabetic.Revision, broken foot arch, hexapod strut malfunction.
Additional Manufacturer Narrative
The reported event that foot arch hoffmann lrf 180mm was alleged of 'instrument breakage identified out of surgery' could be confirmed.Based on investigation, the root cause was attributed to be user and/or patient related.The failure was caused by overloading the device.The device inspection revealed different aspects: on the disconnected metal part from the device: glue is still on the stainless-steel part (after disconnection) and carbon material is still on the stainless steel part (after disconnection).This demonstrates glued connection between metal and carbon part was effective and strong.On the carbon part of the device: the holes in the carbon part are extremely deformed.Fissure between the two holes show a high torque was applied on the foot arch.On the foot arch: a wire bolt was mounted on the foot arch.It can be the reason of an excessive applied torque on the foot arch.We can see the circular marks (fissure and hole deformation).Therefore, the frame was overloaded.A review of the device history for the reported lot did not indicate any abnormalities.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.If any further information is provided, the investigation report will be updated.
Event or Problem Description
This pi is for the second revision of patient's foot arch, and hexapod strut issue.As reported: ".We replace that foot arch with a new one and he[patient] breaks that one the following week.Bring him back to office and revise.While revising we notice the pin in the hexapod strut was starting to come out".Rep indicated patient factor: diabetic.Revision, broken foot arch, hexapod strut malfunction.

• Brand Name: FOOT ARCH HOFFMANN LRF 180MM
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8182768
• Report Number: 0008031020-2018-01083
• Device Sequence Number: 1459950
• Product Code: KTT
• UDI-Device Identifier: 07613252611509
• UDI-Public: 07613252611509
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K163656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2019

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 49346180
• Device Lot Number: 07365L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2019
• Initial Date Received by Manufacturer: 11/27/2018
• Supplement Date Received by Manufacturer: 02/14/2019
• Initial Report FDA Received Date: 12/19/2018
• Supplement Report FDA Received Date: 03/11/2019
• 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
• Patient Age: 60 YR