MAUDE Adverse Event Report: STRYKER GMBH CENTER SCREW T25 DRIVER; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	5901-1122
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "the surgeon was using the center screw t25 driver (5901-1122) on a large t handle (1101-2100) putting the center screw into the baseplate.While turning in the center screw t25 driver in the center screw the tip of the screw driver broke off in the central screw.The surgeon tried using a burr to remove the broken tip and forceps but was unable to.The center screw t25 driver was no longer needed to complete the surgery and was removed from the consignment set." 30 minutes surgical delay to use a bur to try to get it out of the screw and a vice grip.Event occurred during a primary surgery.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed based on the inspection performed.The device inspection revealed the following: the identification of the returned screwdriver was confirmed based on the catalog # and lot # marked.The tip of the instrument is broken.The detached fragment was not returned.The analysis of the broken surface gives indication of a sudden brittle fracture, most probably resulting from excessive bending and/or torsional load.The instrument surface is discolorized and shows signs of light oxidation, most probably resulting from multiple cycles of sterilization.This gives indication that the screwdriver was heavily used before the breakage occurred.Dimensional and material integrity inspection showed the device to be within specification.Based on investigation, the root cause was attributed to an user related issue.The failure was caused by excessive bending and/or torsional applied to the instrument.It must be noted that there is indication that the device was already worn out, which could have helped causing the breakage.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.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "the surgeon was using the center screw t25 driver (5901-1122) on a large t handle (1101-2100) putting the center screw into the baseplate.While turning in the center screw t25 driver in the center screw the tip of the screw driver broke off in the central screw.The surgeon tried using a burr to remove the broken tip and forceps but was unable to.The center screw t25 driver was no longer needed to complete the surgery and was removed from the consignment set." 30 minutes surgical delay to use a bur to try to get it out of the screw and a vice grip.Event occurred during a primary surgery.
Event or Problem Description
As reported: "the surgeon was using the center screw t25 driver (5901-1122) on a large t handle (1101-2100) putting the center screw into the baseplate.While turning in the center screw t25 driver in the center screw the tip of the screw driver broke off in the central screw.The surgeon tried using a burr to remove the broken tip and forceps but was unable to.The center screw t25 driver was no longer needed to complete the surgery and was removed from the consignment set.".30 minutes surgical delay to use a bur to try to get it out of the screw and a vice grip.Event occurred during a primary surgery.
Additional Manufacturer Narrative
Please note the 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 evidences were provided.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.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.H3 other text : device disposition unknown.

• Brand Name: CENTER SCREW T25 DRIVER
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16291974
• Report Number: 0008031020-2023-00044
• Device Sequence Number: 6729358
• Product Code: KWS
• UDI-Device Identifier: 07613327100303
• UDI-Public: 07613327100303
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K130895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 5901-1122
• Device Catalogue Number: 5901-1122
• Device Lot Number: SC27821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2023
• Supplement Date Received by Manufacturer: 03/09/2023; 06/16/2023
• Initial Report FDA Received Date: 02/03/2023
• Supplement Report FDA Received Date: 04/06/2023; 07/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown