MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, TI GAMMA3® Ø12X170MM X 130°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	31302170S
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	10/18/2018
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
Cut out of u lag screw occurs.Patient felt pain on his hip for several weeks and difficult to walk.Then, when falling on (b)(6), visited in the hospital and an x - ray film was taken, it turned out that the lag screw had cut out and reached the acetabular.There is no dislocation of the pieces of the bony skull, and only the lag screw has cut out.As a measure after occurrence, on (b)(6) replaced 120 ° gamma nail.
Additional Manufacturer Narrative
The reported event that trochanteric nail kit, ti gamma3® ø12x170mm x 130° was alleged of issue (implant revision / removal without implant breakage) could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of manufacturing or design related problems were found during the investigation.If device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
Cut out of u lag screw occurs.Patient felt pain on his hip for several weeks and difficult to walk.Then, when falling on (b)(6), visited in the hospital and an x - ray film was taken, it turned out that the lag screw had cut out and reached the acetabular.There is no dislocation of the pieces of the bony skull, and only the lag screw has cut out.As a measure after occurrence, on (b)(6) replaced 120 ° gamma nail.

• Brand Name: TROCHANTERIC NAIL KIT, TI GAMMA3® Ø12X170MM X 130°
• 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: 8074995
• Report Number: 0009610622-2018-01382
• Device Sequence Number: 2325421
• Product Code: HSB
• UDI-Device Identifier: 04546540375148
• UDI-Public: 04546540375148
• Combination Product (Y/N): N
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2018

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 Expiration Date: 03/31/2021
• Device Catalogue Number: 31302170S
• Device Lot Number: K0D136
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/18/2018
• Supplement Date Received by Manufacturer: 11/29/2018
• Initial Report FDA Received Date: 11/15/2018
• Supplement Report FDA Received Date: 12/28/2018
• 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: 59 YR