MAUDE Adverse Event Report: STRYKER GMBH HEXAPOD STRUT, SHORT HOFFMANN LRF 105MM-139MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number 49350020

Device Problems Fracture (1260); Device Slipped (1584)

Patient Problem No Code Available (3191)

Event Date 11/27/2018

Event Type  Injury  

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 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.

Manufacturer Narrative

The reported event that hexapod strut, short hoffmann lrf 105mm-139mm was alleged of 'implant breakage after surgery' could be confirmed.Based on investigation, the root cause was attributed to be manufacturing and supplier related.The failure was caused by manufacturing components out of specifications.The event involved a product problem indicating a non-conformity which is investigated and addressed through a nc and a capa.No further action is required at this time.Product surveillance will continue to monitor complaints of this type for adverse trends.If any further information is provided, the investigation report will be updated.

Event 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: HEXAPOD STRUT, SHORT HOFFMANN LRF 105MM-139MM
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8182788
• MDR Text Key: 130974535
• Report Number: 0008031020-2018-01084
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 07613327294286
• UDI-Public: 07613327294286
• Combination Product (y/n): N
• PMA/PMN Number: K163656
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 49350020
• Device Lot Number: L51361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2019
• Date Manufacturer Received: 02/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR