MAUDE Adverse Event Report: STRYKER GMBH HEXAPOD STRUT, MEDIUM HOFFMANN LRF 131MM-191MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number 49350030

Device Problems Break (1069); Component Falling (1105)

Patient Problem Failure of Implant (1924)

Event Date 06/07/2018

Event Type  Injury  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

Upon a follow-up visit, 3 of 6 hexapod struts were found to have failed.The pins that hold the strut at the hinge were broken.All 6 struts were pulled and replaced.Rep indicated that the pins weren¿t broken.They fell out.They fell completely out of one strut, and halfway out of the other two.

Manufacturer Narrative

The reported event that hexapod strut, medium hoffmann lrf 131mm-191mm 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.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 Description

Upon a follow-up visit, 3 of 6 hexapod struts were found to have failed.The pins that hold the strut at the hinge were broken.All 6 struts were pulled and replaced.Rep indicated that the pins weren¿t broken.They fell out.They fell completely out of one strut, and halfway out of the other two.

• Brand Name: HEXAPOD STRUT, MEDIUM HOFFMANN LRF 131MM-191MM
• 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: 7656724
• MDR Text Key: 112993521
• Report Number: 0008031020-2018-00487
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 07613327294231
• UDI-Public: 07613327294231
• 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: 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 49350030
• Device Lot Number: L53488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2018
• Date Manufacturer Received: 08/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 118