MAUDE Adverse Event Report: STRYKER GMBH SCREWDRIVER BIT AXSOS T15, AO FITTING 4.0MM LOCKING SET; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	702753
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: the customer reported that : "during an ablation of the screw, the head of the screwdriver ref 702753 broke (axos).Use of our material, removal of the screw, without success.Implantation of the plate in 2019 in gap (other establishment) : tibial plate (right) not removed: general anesthesia wasted 2 screws are completely locked in the plate (upper screws) a second anesthesia will be required".The osteosynthesis material was left on the patient.
Event or Problem Description
As reported: the customer reported that : "during an ablation of the screw, the head of the screwdriver ref 702753 broke (axos).Use of our material, removal of the screw, without success.Implantation of the plate in 2019 in gap (other establishment) : tibial plate (right) not removed: general anesthesia wasted 2 screws are completely locked in the plate (upper screws) a second anesthesia will be required".The osteosynthesis material was left on the patient.
Additional Manufacturer Narrative
D9 - corrected to indicate device was not available for return the reported event could not be confirmed, since the device was not returned for evaluation and no other evidences 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.The instructions for use instructs user that: ¿do not hit instruments unless they are specifically intended for impaction.Always treat the instrument carefully to avoid surface damage or alterations to the geometry.The design of the instrument must not be modified in any way.The stryker "instructions for cleaning, sterilization, inspection and maintenance" help to determine whether an instrument is in good condition or must be replaced due to excessive wear or obvious defects.¿ 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 was discarded.

• Brand Name: SCREWDRIVER BIT AXSOS T15, AO FITTING 4.0MM LOCKING SET
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11548343
• Report Number: 0008031020-2021-00100
• Device Sequence Number: 14410546
• Product Code: LXH
• UDI-Device Identifier: 07613327005028
• UDI-Public: 07613327005028
• 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: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2021

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 Model Number: 702753
• Device Catalogue Number: 702753
• Device Lot Number: J03730
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/24/2021
• Supplement Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 03/22/2021
• Supplement Report FDA Received Date: 06/16/2021
• 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
• Patient Age: 40 YR
• Patient Weight: 59