MAUDE Adverse Event Report: STRYKER GMBH SPREADING RECON LAG SCREWDRIVER BIT IMN INSTRUMENTS

Catalog Number 23510220

Device Problems Break (1069); Fracture (1260); Material Deformation (2976); Material Twisted/Bent (2981)

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

Event Date 12/08/2023

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 head of the end cap slipped during removal, causing removal difficulty.The end cap was locked tightly and the tip of the screwdriver was deformed.The reverse threaded screwdriver of the removal instrument was also broken.Other instruments used were also damaged.Finally the end cap and other implants were removed from the patient.".

Event Description

As reported: "the head of the end cap slipped during removal, causing removal difficulty.The end cap was locked tightly and the tip of the screwdriver was deformed.The reverse threaded screwdriver of the removal instrument was also broken.Other instruments used were also damaged.Finally the end cap and other implants were removed from the patient.".

Manufacturer Narrative

Please note correction to section h6 (device code).The kind of damage was not specified for the spreading lag screwdriver in the provided information, a breakage can after the investigation not be confirmed, nevertheless can the complaint be rated as confirmed as the tip of the screwdriver is damaged.The device inspection revealed the following: the visual inspection of the spreading lag screwdriver has shown that the hexagon tip is strongly damaged, the forefront of the tip is almost completely rounded.The tip is slightly twisted in counter-clockwise direction.Both damages indicate that the device was exposed to excessive forces during the end cap removal attempt.Furthermore, a hardness test according to rockwell on the returned item indicates the material being in accordance to the values in the material specification.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.Based on investigation, the root cause was attributed to a user related issue.The event was ultimately caused by using a incorrect screwdriver for the removal of a by strongly tightened end cap that was implanted for more than one year.The initially used spreading recon lag screwdriver bit is cannulated and slotted at the hexagon and no designed to take such high forces.The slot in the hexagon had the effect that the tip was pushed together and as a result the force was no longer distributed as intended over the surfaces of the hexagon, which resulted in damage to the screwdriver and certainly also to the end cap recess.As stated in the t2 alpha femur antegrade operative technique is the set screw or end cap removed with the solid screwdriver bit, long, which is catalog # 2351-0110.After the end cap recess was damaged a removal with the standard screwdriver was not possible anymore.Therefore a end cap removal attempt with the compression screwdriver was made, but the hexagon of this screwdriver is also not designed for end cap removal, the tip smaller and much softer and get therefore easily damaged when excessive forces are applied.The conical extractor, which was used because of the damaged end cap recess, did break as too much torsional and lateral force was applied onto the device.If more information is provided, the case will be reassessed.

• Brand Name: SPREADING RECON LAG SCREWDRIVER BIT IMN INSTRUMENTS
• Type of Device: SCREWDRIVER
• 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: 18425682
• MDR Text Key: 332269985
• Report Number: 0009610622-2024-00004
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 07613327361742
• UDI-Public: 07613327361742
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/09/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 23510220
• Device Lot Number: KP489160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/08/2023
• Initial Date FDA Received: 01/02/2024
• Supplement Dates Manufacturer Received: 03/14/2024
• Supplement Dates FDA Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2023
• 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
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 90 KG