MAUDE Adverse Event Report: STRYKER GMBH SAFETY CLIP (BONE TRANSPORT STRUT) HOFFMANN LRF 13 X 12 X 2.5MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number	49330401
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was not returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition unknown.
Event or Problem Description
3 out of 4 safety clips had popped off of lrf bone transport struts.The patient was only lengthening on 1 out of the 4 total bone transport struts for a possible period of 1 week (this was the amount of time between clinic visits).This may have caused premature consolidation of the bone regenerate that was being transported.The surgeon decided to redo the osteotomy.This was performed during an already planned docking site procedure of the distal segment.Safety clips were placed back on bone transport struts in the clinic.

• Brand Name: SAFETY CLIP (BONE TRANSPORT STRUT) HOFFMANN LRF 13 X 12 X 2.5MM
• 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: 9079694
• Report Number: 0008031020-2019-01287
• Device Sequence Number: 2622636
• Product Code: KTT
• UDI-Device Identifier: 07613327131475
• UDI-Public: 07613327131475
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K153377
• 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): 09/17/2019

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 49330401
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/21/2019
• Initial Report FDA Received Date: 09/17/2019
• 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