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
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/13/2002
Type of Reportable Event	Malfunction
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
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 11 x 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
• 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: 7861900
• Report Number: 0008031020-2018-00597
• Device Sequence Number: 11317176
• Product Code: KTT
• UDI-Device Identifier: 04546540680983
• UDI-Public: 04546540680983
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K111786
• 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
• Report Date (Section B): 09/10/2018

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: Lay User/Patient
• Device Catalogue Number: 49221010
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2018
• Initial Report FDA Received Date: 09/10/2018
• 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: Other