MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø11X280MM X 130°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	34301280S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
Sterile packing was defective.Implant could not be used.Outer packing was not damaged.Another nail was used to complete the medical procedure.Surgical delay of 2 minutes not longer.No other consequences reported.
Event or Problem Description
Sterile packing was defective.Implant could not be used.Outer packing was not damaged.Another nail was used to complete the medical procedure.Surgical delay of 2minutes not longer.No other consequences reported.
Additional Manufacturer Narrative
The reported event that long nail kit r1.5, ti, right gamma3® ø11x280mm x 130° packaging blister was damaged could be confirmed.A deviation due to incorrect packaging of the nail kit into the cardboard box could be excluded as the found damage shows significant traces of an impact or contact by another object.No discrepancies were reported during incoming inspection at distribution site.Thus, we exclude that the damage was generated during the packaging process or during shipment from stryker kiel to the distribution site.Furthermore, according to event details the damaged blister was noticed ¿during opening the packing¿.The damage could have been best presented in original condition, which have been possible in this case.The crack is obviously visible and stripping off the tyvek lid® was not necessary in this case.Based on the information given an exact root cause could not be determined but it could not be excluded that the damage occurred during handling/storage at the hospital site, which is beyond the manufacturer¿s control.However, the originator of the damage found cannot be determined in this case.The device inspection revealed the following: we received a long nail kit r1.5, ti, right gamma3® ø11x280mm x 130° within its original cardboard box and without overwrapping.After unpacking a cracked blister becomes visible.The tyvek® lid was already completely stripped off.The nail and set screw were not placed in original position, which is supported by the imprints at the pe-foam blocks.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø11X280MM 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: 8182748
• Report Number: 0009610622-2018-01516
• Device Sequence Number: 2792018
• Product Code: HSB
• UDI-Device Identifier: 07613252273943
• UDI-Public: 07613252273943
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 34301280S
• Device Lot Number: K0948A7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2019
• Initial Date Received by Manufacturer: 11/28/2018
• Supplement Date Received by Manufacturer: 02/05/2019
• Initial Report FDA Received Date: 12/19/2018
• Supplement Report FDA Received Date: 03/05/2019
• 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