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	11/20/2018
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 disposition is unknown.
Event or Problem Description
This pi is for the first revision of the patient's foot arch.As reported: "patient was low weight bearing and broke a foot arch.We replace[d] the foot arch with new one." rep indicated patient factor: diabetic.
Event or Problem Description
This pi is for the first revision of the patient's foot arch.As reported: "patient was low weight bearing and broke a foot arch.We replace[d] the foot arch with new one.".Rep indicated patient factor: diabetic.
Additional Manufacturer Narrative
The reported event that foot arch hoffmann lrf 180mm was alleged of 'instrument breakage identified out of surgery' could be confirmed.The root cause of this breakage has been identified as a design/manufacturing issue.This problem has already been addressed through a capa and a new design and gluing process have been implemented: the new drawing is already released.Design change was performed for last revision of the drawing in order to increase the strength connection between metal and carbon parts of hoffmann lrf foot archs.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.

• 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: 8182772
• Report Number: 0008031020-2018-01082
• Device Sequence Number: 16648178
• 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: K130907
• 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): 03/05/2019

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: 02812R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2019
• Initial Date Received by Manufacturer: 11/27/2018
• Supplement Date Received by Manufacturer: 02/04/2019
• Initial Report FDA Received Date: 12/19/2018
• Supplement Report FDA Received Date: 03/05/2019
• 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