MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TIBIAL NAIL, STANDARD T2 TIBIA Ø11X345 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1822-1134S
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/29/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that whilst connecting a t2 tibial nail to the t2 suprapatella nail adaptor, the surgeon noted that although the nail was correctly aligned with the adaptor, it still had some movement.He tightened the bolt as much as he could to no avail.He decided to remove the bolt and try again only to find that this was not possible.The bolt appeared to have cold welded into the nail.The surgeon had to switch to the infrapatella incision.He had already completed reaming through the suprapatella incision so the change was relatively simple.He reamed to the next nail diameter and inserted the nail using the t2 infrapatella nail adaptor.There was a delay of about 10 minutes in the procedure whilst the surgeon tried to separate the nail from the bolt.The patient was adversely affected, as an extra incision had to be made to accommodate the new entry point for the nail.
Event or Problem Description
It was reported that whilst connecting a t2 tibial nail to the t2 suprapatella nail adaptor, the surgeon noted that although the nail was correctly aligned with the adaptor, it still had some movement.He tightened the bolt as much as he could to no avail.He decided to remove the bolt and try again only to find that this was not possible.The bolt appeared to have cold welded into the nail.The surgeon had to switch to the infrapatella incision.He had already completed reaming through the suprapatella incision so the change was relatively simple.He reamed to the next nail diameter and inserted the nail using the t2 infrapatella nail adaptor.There was a delay of about 10 minutes in the procedure whilst the surgeon tried to separate the nail from the bolt.The patient was adversely affected, as an extra incision had to be made to accommodate the new entry point for the nail.
Additional Manufacturer Narrative
Please note correction to d9/h3 as the device was not returned for evaluation.The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence were provided.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 material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.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.If device is returned or any further information is provided, the investigation report will be reassessed.H3 other text : device disposition unknown.

• Brand Name: TIBIAL NAIL, STANDARD T2 TIBIA Ø11X345 MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14787444
• Report Number: 0009610622-2022-00276
• Device Sequence Number: 4843623
• Product Code: HSB
• UDI-Device Identifier: 04546540198044
• UDI-Public: 04546540198044
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K203819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2022

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: Health Professional
• Device Expiration Date: 09/30/2024
• Device Model Number: 1822-1134S
• Device Catalogue Number: 18221134S
• Device Lot Number: K084BB9
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/29/2022
• Supplement Date Received by Manufacturer: 07/27/2022
• Initial Report FDA Received Date: 06/23/2022
• Supplement Report FDA Received Date: 08/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown