MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R2.0, TI, RIGHT GAMMA3® Ø11X360MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	32250360S
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	10/09/2015
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.Device disposition is unknown.
Event or Problem Description
The manufacturer became aware of adverse events from the (b)(6) hip fracture register.The title of this report is ¿gamma 3 in the (b)(6) hip fracture register¿ which is associated with the gamma3 locking nail system, within that report, post-operative complications/ adverse events were reported, which occurred between (b)(6)2005 and (b)(6) 2016.A review of the complaint handling database revealed that the events have not been reported previously to stryker, therefore 290 complaints were initiated for the revision surgeries retrospectively for different adverse events mentioned in the report.This product inquiry addresses revision surgery due to a new fracture around implant.Re-ostesynthesis was performed.Thirty four (34) out of 290 cases.

• Brand Name: LONG NAIL KIT R2.0, TI, RIGHT GAMMA3® Ø11X360MM X 125°
• 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: 7771589
• Report Number: 0009610622-2018-00629
• Device Sequence Number: 11110665
• Product Code: HSB
• UDI-Device Identifier: 07613153312772
• UDI-Public: 07613153312772
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/10/2018

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: Lay User/Patient
• Device Catalogue Number: 32250360S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2018
• Initial Report FDA Received Date: 08/10/2018
• 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: Required Intervention