MAUDE Adverse Event Report: STRYKER GMBH ROD TO ROD COUPLING HOFFMANN 3 Ø5/8/11MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number 49221010

Device Problems Loose or Intermittent Connection (1371); Device Slipped (1584)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/13/2002

Event Type  malfunction  

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 Description

The hoffmann 3 kickstand for an ankle delta dfame continues to loosen and slide out.Delta couplings we¿re fully tightened and has happened before per the surgeon (never notified of prior issue) when connecting the kickstand to the transfixing pin or to the 11x 350 mm connecting rods.He feels as if the couplings were tight as possible with both the t handle and wrench.Issue was noticed post surgery when the stability of the frame did not remain intact 2 days post surgery.

• Brand Name: ROD TO ROD COUPLING HOFFMANN 3 Ø5/8/11MM
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7861899
• MDR Text Key: 119945299
• Report Number: 0008031020-2018-00596
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 04546540680983
• UDI-Public: 04546540680983
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111786
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 49221010
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other