MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø11X360MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	34251360S
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.Device remains implanted.
Event or Problem Description
It was reported: "once doctor had lag screw in correct position on the first nail, he put in the set screw but it did not engage into the proximal part of nail.It spun loosely and would not advance further distally or back out to try and re-position.The same exact outcome happened on the second nail.The set screw entered the nail and got stuck.Doctor tried a couple different set screwdrivers to try and back it out.Both nails resulted with stuck set screws that did not engage into the lag screws.Delay in surgery: 20 minutes.Procedure was completed successfully.The doctor concluded to leave both of the nails in.No additional surgery is planned.No adverse consequences reported.
Event or Problem Description
It was reported: "once doctor had lag screw in correct position on the first nail, he put in the set screw but it did not engage into the proximal part of nail.It spun loosely and would not advance further distally or back out to try and re-position.The same exact outcome happened on the second nail.The set screw entered the nail and got stuck.Doctor tried a couple different set screwdrivers to try and back it out.Both nails resulted with stuck set screws that did not engage into the lag screws.Delay in surgery: 20 minutes.Procedure was completed successfully.The doctor concluded to leave both of the nails in.No additional surgery is planned.No adverse consequences reported.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.More information as well as reported device must be available in order to determine the exact root cause.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.A review of the labeling did not indicate any abnormalities.If the device is returned or any further information is provided, the complaint report will be updated.

• Brand Name: LONG NAIL KIT R1.5, 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: 9216237
• Report Number: 0009610622-2019-00873
• Device Sequence Number: 11180554
• Product Code: HSB
• UDI-Device Identifier: 07613252273837
• UDI-Public: 07613252273837
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2020

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: 06/30/2023
• Device Catalogue Number: 34251360S
• Device Lot Number: K0906F8
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/27/2019
• Supplement Date Received by Manufacturer: 12/10/2019
• Initial Report FDA Received Date: 10/21/2019
• Supplement Report FDA Received Date: 01/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR