MAUDE Adverse Event Report: STRYKER GMBH STRIKE PLATE T2 FEMUR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 1806-0150

Device Problems Material Fragmentation (1261); Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/31/2023

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

As reported: "the impact tool (ref# (b)(6) ) would not screw into the brand new t2alpha femur targeting device (ref# (b)(6) ) even after several attempts.Everyone involved at the table tried.Rather, metal shavings were then abraded, but none of them did get into the patient.However, in order to then drive the nail in so as to be able to perform the surgery, the surgeon had to make do and hammered the impactor into the targeting device.".

Manufacturer Narrative

Please note correction to d3 (manufacturing entity) and d4 (lot#); the reported event could be confirmed, since the strike plate cannot be attached to the targeting arm anymore in the received condition.The device inspection revealed the following: the visual inspection has shown that the thread flanks at the strike plate are totally flattened.Compared with the thread in the targeting arm it is likely that the first three or four thread flanks did get damaged during the description mentioned hammering and the rest of the thread flanks did get damaged during a previous procedure while the strike was not fully inserted and tightened into the counterpart as required.The evaluation has also shown that the top of the strike plate is in a excessively used condition, there are marks of numerous hammer blows visible, including some strong hits on the edge.There are also marks below the head visible and there is a burr at the hexagon present.A review of the device history for the reported lot did not indicate any abnormalities.The device was manufactured in the year 2015 and we are not aware of any other complaint of this nature for the reported lot number.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.Based on investigation, the root cause was attributed to a user related issue.The event was caused by the insertion of strike plate with a thread that was previously damaged into the intact thread of the targeting arm, this did lead to a deformation of the thread flanks and finally to the reported event.If more information is provided, the case will be reassessed.

Event Description

As reported: "the impact tool (ref# (b)(4) would not screw into the brand new t2alpha femur targeting device (ref# (b)(4) even after several attempts.Everyone involved at the table tried.Rather, metal shavings were then abraded, but none of them did get into the patient.However, in order to then drive the nail in so as to be able to perform the surgery, the surgeon had to make do and hammered the impactor into the targeting device.".

• Brand Name: STRIKE PLATE T2 FEMUR
• Type of Device: 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: 16849252
• MDR Text Key: 314388246
• Report Number: 0009610622-2023-00142
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 04546540196088
• UDI-Public: 04546540196088
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1806-0150
• Device Catalogue Number: 18060150
• Device Lot Number: K07627B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1