MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø10X380MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	35250380S
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/15/2018
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.Legal matter.
Event or Problem Description
It's alleged by the attorney, through the filing of a lawsuit, that the plaintiff was injured by a stryker gamma nail on (b)(6) 2018.
Event or Problem Description
It's alleged by the attorney, through the filing of a lawsuit, that the plaintiff was injured by a stryker gamma nail on (b)(6) 2018.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.More detailed information about the complaint event as well as the affected device, x-ray and op-report must be available in order to determine the root cause of the complaint event.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.Based on the past complaint history and rmf the insertion of the gamma-nail should be done without force.Insertion with force may cause an iatrogenic fracture.No indications of manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.The operative technique states that, ¿1 danger: the nail must progress smoothly, without excessive force.If too much resistance is encountered, removal of the nail and additional reaming is recommended." if device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø10X380MM 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: 8553342
• Report Number: 0009610622-2019-00227
• Device Sequence Number: 14061248
• Product Code: HSB
• UDI-Device Identifier: 04546540375759
• UDI-Public: 04546540375759
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2019

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: No Information
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: 35250380S
• Device Lot Number: K0320F4B
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/04/2019
• Supplement Date Received by Manufacturer: 06/04/2019
• Initial Report FDA Received Date: 04/25/2019
• Supplement Report FDA Received Date: 06/25/2019
• 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: Other