MAUDE Adverse Event Report: STRYKER GMBH TARGET DEVICE, HUMERUS T2; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18060143
Medical Device Problem Codes	Break (1069); Crack (1135); Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/10/2024
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
'broken target arm t2 humerus was reported.
Event or Problem Description
'broken target arm t2 humerus was reported.
Additional Manufacturer Narrative
Corrections: please refer to section h6 device code.The reported event could be confirmed since the device was returned for evaluation and matches the alleged failure.The device inspection revealed the following: the outer surface of target device found worn out and discolored, marking on the device has turned fawn from white.This indicates that the device is in use since long and has gone through numerous cleaning and sterilization cycles.A linear crack observed in the handle of the device running from proximal hole to the distal hole till the end indicating that the handle has experienced excess force either due to external hit or excess radial force due to protection sleeve.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.The instructions for use clearly states do not hit instruments unless they are specifically intended for impaction.Never hit targeting devices or elastosil handles other than those with an integrated strike plate.Based on investigation, the root cause was attributed to a user related issue.The failure was probably caused by improper handling combined to normal wear and tear of the target device.It is possible that excessive loads were applied from the protection sleeve on the carbon fiber handle or that it was directly hit during surgery which should be avoided.Also, the device was manufactured in 2007 which indicates that it has gone through numerous sterilization cycles for more than 15 years.Therefore, the device was already worn out before the reported failure occurred.If more information is provided, the case will be reassessed.

• Brand Name: TARGET DEVICE, HUMERUS T2
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19696481
• Report Number: 0009610622-2024-00342
• Device Sequence Number: 8027578
• Product Code: LXH
• UDI-Device Identifier: 04546540196071
• UDI-Public: 04546540196071
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2024

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 Catalogue Number: 18060143
• Device Lot Number: KME901652
• 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: 06/11/2024
• Supplement Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 07/08/2024
• Supplement Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2007
• 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