MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNIVERSAL ROD T2 FEMUR Ø9 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18060110
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/31/2018
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
The pharmacist at the hospital reported the following event : "i would like to contact you for a declaration of materiovigilance on a guide for nail guide t2 (restérilisable material ref 1806-0125k134075 / 1806-0110k537887).During an intervention on (b)(6) 2018, the screw thread connecting the two parts of the guide broke in the femoral shaft during the attempt to reduce a femoral fracture, resulting in an additional incision on the leg to be able to access the lower end of the instrument in order to be able to remove it.An additional incision had to be made on the leg to gain access to the lower end of the instrument in order to remove it.
Additional Manufacturer Narrative
The reported event that universal rod t2 femur ø9 mm was alleged of instruments - broken, deformed, worn or scratched could be confirmed.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by improper handling.The device inspection revealed the following: the returned device shows traces of a high frequently usage.The thread of the universal rod was found completely broken off.It broke at the last windings.The breakage surfaces show a smooth structure.Plastic deformation along the breakage surfaces is not found.Furthermore, hammer signs were found on the handle surface.The broken off part was returned as well and was found to be stuck in the counterpart, which was returned as well.The breakage surfaces show the typically structure of a brittle fracture, most likely due to a bending overload.Referring to the very long period since manufacturing (manufactured in 2011) the device has reached the end of its useful service-life and had fulfilled its tasks in former surgeries as intended, until the reported event, without problems reported.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.
Event or Problem Description
The pharmacist at the hospital reported the following event : "i would like to contact you for a declaration of materiovigilance on a guide for nail guide t2 (restérilisable material ref 1806-0125k134075 / 1806-0110k537887).During an intervention on (b)(6) 2018, the screw thread connecting the two parts of the guide broke in the femoral shaft during the attempt to reduce a femoral fracture, resulting in an additional incision on the leg to be able to access the lower end of the instrument in order to be able to remove it.An additional incision had to be made on the leg to gain access to the lower end of the instrument in order to remove it.
Event or Problem Description
The pharmacist at the hospital reported the following event : "i would like to contact you for a declaration of materiovigilance on a guide for nail guide t2 (restérilisable material ref 1806-0125k134075 / 1806-0110k537887).During an intervention on (b)(6) 2018, the screw thread connecting the two parts of the guide broke in the femoral shaft during the attempt to reduce a femoral fracture, resulting in an additional incision on the leg to be able to access the lower end of the instrument in order to be able to remove it.An additional incision had to be made on the leg to gain access to the lower end of the instrument in order to remove it.
Additional Manufacturer Narrative
Investigation revealed the subject product to be a concomitant item.The reduction spoon t2 femur did not contribute to the reported event of broken off tip of universal rod t2 femur.

• Brand Name: UNIVERSAL ROD T2 FEMUR Ø9 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 8171154
• Report Number: 0009610622-2018-01513
• Device Sequence Number: 13890214
• Product Code: LXH
• UDI-Device Identifier: 04546540196040
• UDI-Public: 04546540196040
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/06/2019

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 18060110
• Device Lot Number: K537887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Initial Date Received by Manufacturer: 11/21/2018
• Supplement Date Received by Manufacturer: 02/01/2019; 03/06/2019
• Initial Report FDA Received Date: 12/17/2018
• Supplement Report FDA Received Date: 02/26/2019; 03/06/2019
• 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