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	08/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.Device disposition unknown.
Event or Problem Description
It was reported that a table top place bender broke at the base of the handle while in surgery.
Event or Problem Description
It was reported that a table top place bender broke at the base of the handle while in surgery.
Additional Manufacturer Narrative
Please note the correction to d9/h3 as the device was returned for evaluation.Please also note the corrections to h6 method, h6 results and h6 conclusion codes.The reported event could be confirmed, since the device is broken as complained.The device inspection revealed the following: the visual inspection has shown that the base lever, where the lever arm is fixated, is broken apart at the crossover from the smaller to the bigger diameter of the cylinder head screw holes.The damage pattern shows that the fracture surface was torn apart at very high forces.The inspection of the recess at the cylinder head screws shows that there are deformations at the top of the recess visible, this is an indication for a manipulation at the screw that occurred post-manufacturing.Also at the lever arm are stress marks in the area of the base lever visible, these marks are also an indication that the arm was moved post-manufacturing.In general is the device is in a used condition, there are wear marks at the bent sleeves visible.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.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.Based on 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.A manipulation at the screws in this area may also have played a certain role as an over-tightening or insufficient tightening the screws could have resulted in a stress riser in the area of the breakage.If more information is provided, the case will be reassessed.

• 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: 15876075
• Report Number: 0008031020-2022-00649
• Device Sequence Number: 2492824
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2023

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2022
• Supplement Date Received by Manufacturer: 01/04/2023
• Initial Report FDA Received Date: 11/29/2022
• Supplement Report FDA Received Date: 02/01/2023
• 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