MAUDE Adverse Event Report: STRYKER GMBH CONNECTING ROD HOFFMANN 3 Ø11X400MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number	49228400
Health Effect - Clinical Code	Fall (1848)
Date of Event	11/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
The doctor reported to sales rep that due to the accidentally falling down of the patient 1 month ago after surgery, a hoffman 3 pin-hole connector was disconnected and the stability of the assembly was lost.The patient came to hospital and hoffman system was adjusted with another connectors in order to be restored the stability.

• Brand Name: CONNECTING ROD HOFFMANN 3 Ø11X400MM
• 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: 8210690
• Report Number: 0008031020-2019-00008
• Device Sequence Number: 10813654
• Product Code: KTT
• UDI-Device Identifier: 04546540681157
• UDI-Public: 04546540681157
• Combination Product (Y/N): N
• Initial Reporter Country: RO
• PMA/510(K) Number: K111786
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 49228400
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2018
• Initial Report FDA Received Date: 01/02/2019
• 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: Required Intervention