MAUDE Adverse Event Report: STRYKER GMBH TABLE PLATE BENDER SPS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	702900
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "table top plate bender broke at the base of the handle while in surgery.Delay in surgery, unsure of time.".
Additional Manufacturer Narrative
Please note the correction to g1: manufacturing site and h6 method codes.The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the visual inspection has shown that the base lever, where the lever arm is fixated, is cracked at the crossover from the smaller to the bigger diameter of the cylinder head screw holes.The damage pattern shows that the surface was cracked due to high forces applied by the lever.Also at the base of the lever arm are stress marks and a dent is visible from the usage.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.Nevertheless, it can be mentioned that the design of the base lever has been improved in the meantime as part of our continuous improvements to avoid such an occurrence in the future.A review of the labeling did not indicate any abnormalities.Based on the investigation, the root cause was attributed to a user-related issue.The failure was caused by a mechanical overload during the bending of a plate.If any further information is provided, the complaint report will be updated.
Event or Problem Description
As reported: "table top plate bender broke at the base of the handle while in surgery.Delay in surgery, unsure of time.".

• Brand Name: TABLE PLATE BENDER SPS
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16283658
• Report Number: 0008031020-2023-00043
• Device Sequence Number: 4779268
• Product Code: LXH
• UDI-Device Identifier: 04546540363831
• UDI-Public: 04546540363831
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2023

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: 702900
• Device Catalogue Number: 702900
• Device Lot Number: 12125G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/10/2023
• Supplement Date Received by Manufacturer: 04/03/2023
• Initial Report FDA Received Date: 02/02/2023
• Supplement Report FDA Received Date: 04/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2020
• 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