MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R2.0, TI, LEFT GAMMA3® Ø11X320MM X 120°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	33200320S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/24/2019
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 evaluated by mfr: device disposition unknown.
Event or Problem Description
Nail break in pertrochanteric fracture.Unanticipated surgical procedure.
Additional Manufacturer Narrative
(results & conclusion).The reported event could be confirmed, however the device was not returned but the x-ray images provided by the customer confirm the reported failure mode.Medical expert opinion revealed the following: "the x-ray shows a reversed oblique subtrochanteric fracture of the left hip with dislocation of the lesser trochanter.The fracture has been addressed with a gamma nail and one cerclage in a poor position.The remaining fracture gap can be seen on the ap view showing at least 0,5-1cm gap on the height of the intertrochanteric line and a rotational incongruence showing at the peak of the lateral distal fragment.The fracture did not heal and the treatment ended up in failure.As a result the hip had to be replaced.If the initial procedure was done properly there would have been a chance of a successful osteosynthesis.The implant is not to blame in this case." based on the investigation the root cause was attributed to user related issue.The failure was caused by poor positioning of nail.The fracture gap was not successfully reduced, as a result of which proper bone consolidation couldn¿t take place.Consequently, additional stress on nail led to its breakage.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 material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
Nail break in pertrochanteric fracture.Unanticipated surgical procedure.

• Brand Name: LONG NAIL KIT R2.0, TI, LEFT GAMMA3® Ø11X320MM X 120°
• 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: 8739917
• Report Number: 0009610622-2019-00524
• Device Sequence Number: 19342950
• Product Code: HSB
• UDI-Device Identifier: 07613153313229
• UDI-Public: 07613153313229
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2019

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 Expiration Date: 01/31/2020
• Device Catalogue Number: 33200320S
• Device Lot Number: K0B3A5C
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/07/2019
• Supplement Date Received by Manufacturer: 08/20/2019
• Initial Report FDA Received Date: 06/27/2019
• Supplement Report FDA Received Date: 09/18/2019
• 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
• Patient Age: 73 YR