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

Catalog Number	18060125
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
Please note corrections to d4 (catalog number, lot code, gtin).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.
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.

• Brand Name: REDUCTION SPOON 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: 8171155
• Report Number: 0009610622-2018-01514
• Device Sequence Number: 2070338
• Product Code: LXH
• UDI-Device Identifier: 04546540196019
• UDI-Public: 04546540196019
• 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
• 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: 18060125
• Device Lot Number: K134075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2018
• Initial Date Received by Manufacturer: 11/21/2018
• Supplement Date Received by Manufacturer: 03/06/2019
• Initial Report FDA Received Date: 12/17/2018
• Supplement Report FDA Received Date: 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