MAUDE Adverse Event Report: STRYKER GMBH FOOT ARCH HOFFMANN LRF 140MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number	49346140
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported that a kit had foot arches that were "faulty"; the bonding on the posts are loose and detach from the carbon arch.No associated procedure.
Event or Problem Description
It was reported that a kit had foot arches that were "faulty"; the bonding on the posts are loose and detach from the carbon arch.No associated procedure.
Additional Manufacturer Narrative
Correction: sections d10, h3 the reported event could be confirmed via pictures that were sent, however the device was not returned.From the pictures sent, some small deformations can be noticed on the material of the two arches.Based on the investigation, the root cause was attributed to be manufacturing related.A nonconformance has been initiated to address this event.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.If any further information is provided, the investigation report will be updated.H3 other text : device disposition unknown.

• Brand Name: FOOT ARCH HOFFMANN LRF 140MM
• 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: 8680858
• Report Number: 0008031020-2019-00536
• Device Sequence Number: 2257165
• Product Code: KTT
• UDI-Device Identifier: 07613252611479
• UDI-Public: 07613252611479
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K130907
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 49346140
• Device Lot Number: 02821R
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/20/2019
• Supplement Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 06/07/2019
• Supplement Report FDA Received Date: 08/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1