MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TARGETING ARM TNS T2 TIBIA; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-1001
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2022
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
It was reported that the drill holes in the t2 tibial targeting arm didn't align with the screw holes of the nail.This was discovered when assembling the nail on to the targeting device, prior to any patient involvement.
Event or Problem Description
It was reported that the drill holes in the t2 tibial targeting arm didn't align with the screw holes of the nail.This was discovered when assembling the nail on to the targeting device, prior to any patient involvement.
Additional Manufacturer Narrative
The reported event could be confirmed, since physical evaluation revealed slight play at the quick lock ring which is resulting in targeting inaccuracy.The device inspection revealed the following: the received targeting arm shows traces of a long and intense use identified by the general appearance of the surfaces and by the appearance of the white printings, which turned from white to fawn [an indication for a high number of sterilization cycles].Furthermore, scratches are visible at the metal surface inside the quick lock ring of the targeting arm [reception for the nail handle].It appears that due to certain sterilization cycles the attributes of connection itself and materials of the connection may change resulting in micro movements and therewith loosening of or within the connection by delaminating during long term use.For investigation in potential risk in causing damage to the nail with the drill during drilling, we performed a test [simulation of pre-operative check which is required according to instructions for use].Functional test revealed that the bayonet cap [the unit in the carbon] does indeed have slight play.The pre-operative test performed revealed targeting accuracy not being as intended.The drill could not be passed into the nail through the static drill holes at both [left/right] sides of the targeting arm.The targeting accuracy was affected or restricted by the slight play of quick lock ring.Nevertheless, both [targeting arm and sample nail handle] could be assembled as intended.Each instrument will inevitably suffer from intense and frequent use.Referring to the long period since manufacturing [manufactured 2016] the device has reached the end of its useful service-life and should be sorted out.Evaluation revealed that in this case the event is linked to normal wear and tear caused, among others, by a high number of sterilization cycles.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 brochure instructions for cleaning, sterilization, inspection and maintenance shows several examples of signs of damage and recommends removing of such products and points out ¿careful inspection and functional test of the device before use is the best method of determining the end of serviceable life for the medical device¿.Finally, ifu points out that ¿before every operation, ensure that all devices to be used during the operation function correctly with each other¿.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.

• Brand Name: TARGETING ARM TNS T2 TIBIA
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• 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: 16064216
• Report Number: 0009610622-2022-00606
• Device Sequence Number: 20516552
• Product Code: LXH
• UDI-Device Identifier: 04546540196521
• UDI-Public: 04546540196521
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2023

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: 1806-1001
• Device Catalogue Number: 18061001
• Device Lot Number: KH161045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2022
• Supplement Date Received by Manufacturer: 02/21/2023
• Initial Report FDA Received Date: 12/28/2022
• Supplement Report FDA Received Date: 03/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2016
• 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