MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LAG SCREW, TI GAMMA3® Ø10.5X105MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	30600105S
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.
Event or Problem Description
It was reported that patient's right femur was revised due to lateral hip pain.A 10.5x105mm lag screw was revised to a 10.5x90mm lag screw.Rep has provided pre-op and post-op x-rays and reported that additional x-rays, medical records, and further information will not be released by the hospital or surgeon.Rep indicated that he did not observe any damage to the nail.The nail was not revised.

• Brand Name: LAG SCREW, TI GAMMA3® Ø10.5X105MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 7975456
• Report Number: 0009610622-2018-01346
• Device Sequence Number: 1093650
• Product Code: HSB
• UDI-Device Identifier: 04546540374950
• UDI-Public: 04546540374950
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K032244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/17/2018

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: No Information
• Device Catalogue Number: 30600105S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2018
• Initial Report FDA Received Date: 10/17/2018
• 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: Required Intervention
• Patient Age: 69 YR
• Patient Weight: 98