MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN DRILL; INSTRUMENT

Catalog Number UNK_KIE

Device Problem Failure to Align (2522)

Patient Problem Limb Fracture (4518)

Event Date 08/24/2021

Event Type  Injury  

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

Event Description

The customer reported that: "during the installation of a stryker t2 femur nail, after checking the various screw connections on the instrumentation table of the various screws: ok.The surgeon tried a trochanter screw with the aiming device ref: (b)(4) but the drill bit was not in the right axis: out of the nail.Another surgeon then used the same equipment and the same patient to put two screws in cephalad, the first screw without any problem but the second screw deviated from the first and came out laterally of the head.Clinical consequences: removal of the nail holder to insert the second cephalic screw with hands up.During the procedure, it was necessary to use materials other than those present in the ancillary equipment.The procedure could be completed but not with the expected results.The procedure was delayed by 120 min.Clinical consequences for the patient: supplementary fracture of the femur".

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.The device inspection was not possible as the product was not returned for investigation.The batch record and raw material certificate could not be reviewed because the affected device was not returned, and the lot number was not communicated.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 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 is unknown.

Event Description

The customer reported that: "during the installation of a stryker t2 femur nail, after checking the various screw connections on the instrumentation table of the various screws: ok.The surgeon tried a trochanter screw with the aiming device ref: 2351-0070 but the drill bit was not in the right axis: out of the nail.Another surgeon then used the same equipment and the same patient to put two screws in cephalad, the first screw without any problem but the second screw deviated from the first and came out laterally of the head.Clinical consequences: removal of the nail holder to insert the second cephalic screw with hands up.During the procedure, it was necessary to use materials other than those present in the ancillary equipment.The procedure could be completed but not with the expected results.The procedure was delayed by 120 min.Clinical consequences for the patient: supplementary fracture of the femur.".

• Brand Name: UNKNOWN DRILL
• Type of Device: INSTRUMENT
• 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: marilyne chaumont ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12479936
• MDR Text Key: 271639616
• Report Number: 0009610622-2021-00693
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 11/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_KIE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other