MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; SCALPEL, ULTRASONIC, REPROCESSED

Model Number HARH36

Device Problem Fracture (1260)

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

Event Date 01/25/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned to stryker sustainability solutions for evaluation.Upon visual inspection of the received complaint device, evidence of clinical use was identified.The blade was fractured and separated from the device tip.The teflon pad, handle and contact rings appear to be intact.Inspection of the fractured blade revealed signs of gouging and outer coating erosion as a result of activating against solid/hard materials.No damage to the actuating shaft was observed.A review of the dhr supports that the device met all inspection and test criteria prior to release from stryker.Therefore, the most likely root cause(s) are: too much force or torque applied to instrument, or grasping/pulling; incidental and prolonged activation against solid surfaces, such as bone or plastic.The instructions for use (ifu) state: use the torque wrench (already mounted to the shaft) to tighten the blade onto the hand piece.Turn the torque wrench clockwise while holding only the gray hand piece until it clicks twice indicating that sufficient torque has been applied to secure the blade.Do not attempt to bend, sharpen, or otherwise alter the shape of the blade.Doing so may cause blade failure and user or patient injury.Avoid contact with any and all other instruments while the instrument is activated.Contact with staples, clips or other instruments while the instrument is activated may result in cracked or broken blades.Note: do not use any other means than the torque wrench to attach or detach the instrument from the hand piece.Note: do not torque the instrument by hand without the torque wrench or damage may occur to the hand piece.The reported event will continue to be monitored through post-market surveillance.

Event Description

The tip of a harmonic scalpel was reported broken during procedure.There was no patient injury, medical intervention, or extended procedure time reported.These are commonly used devices that are readily available.

Manufacturer Narrative

Updates to: g3, g6, h2, h10.Reprocessed ultrasonic scalpels are hand-held instruments designed by the original equipment manufacturer to be used as part of the ultrasonic surgical system.These devices cut and coagulate tissue simultaneously by using ultrasonic vibrations when attached to the ultrasonic handpiece and electrosurgical unit.These devices are used to cut and coagulate tissue and vessels up to 5mm in size (harh23/36/45 indicated for use up to 7mm).Ultrasonic scalpels are used in open and laparoscopic general, plastic, pediatric, urologic, and gynecologic procedures.They are indicated for use in general and endoscopic surgery to cut and coagulate soft tissue when hemostasis is desired with minimal risk of burns.A review of mdrs filed since (b)(6) 2014, through (b)(6) 2022, was conducted.Since (b)(6), 2014, a total of 9 serious injury mdrs have been filed.After further analysis of the reported events, we are requesting fda concurrence with the proposed decision to discontinue filing mdrs for ultrasonic scalpel blade breaking and fully detaching for the following reasons: the procedure related to the initial serious injury mdr was completed.Successfully.Through complaint investigation, the most likely root causes include: applying improper or unnecessary directional or rotational force to connect instrument to hand piece.Jaws/blade subassembly damage or separation.Too much force or torque applied to instrument, or grasping/pulling.Reprocessed ultrasonic scalpels instructions for use (ifu) clearly states to inspect the reprocessed ultrasonic scalpels for overall condition and physical.Integrity.Do not use the reprocessed ultrasonic scalpels if any damage is noted.Ifus can be downloaded at http://sustainability.Stryker.Com/ifu.The occurrence rate of the malfunction since january 9, 2014, is low.The occurrence rate of the failure mode causing or contributing to a serious injury since (b)(6) 2014, is remote.Each customer communication letter recommends that product ifus be printed, reviewed, and readily available for operator reference during procedures when using our devices.Based on the analysis of additional data, the likelihood of the failure mode of ultrasonic scalpel blade breaking and fully detaching, causing or contributing to another serious injury should the malfunction recur, is considered remote.We will continue to report these malfunctions until fda has responded and granted the exemption request.As requested, we will email mdrpolicy.Fda.Hhs.Gov the mdr report number in which our firm¿s decision is documented upon submission of this supplemental mdr.

Event Description

The tip of a harmonic scalpel was reported broken during procedure.There was no patient injury, medical intervention, or extended procedure time reported.These are commonly used devices that are readily available.

• Brand Name: NA
• Type of Device: SCALPEL, ULTRASONIC, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5300 region ct; lakeland FL 33815
• Manufacturer (Section G): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5300 region ct; lakeland FL 33815
• Manufacturer Contact: andy dobos ; 1810 w. drake drive; tempe, AZ 85283 ; 8888883433
• MDR Report Key: 13997666
• MDR Text Key: 291624455
• Report Number: 0001056128-2022-00016
• Device Sequence Number: 1
• Product Code: NLQ
• UDI-Device Identifier: 07613327346251
• UDI-Public: 07613327346251
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161693
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/20/2022

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 Model Number: HARH36
• Device Catalogue Number: HARH36RR
• Device Lot Number: 13248143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2022
• Initial Date FDA Received: 04/04/2022
• Supplement Dates Manufacturer Received: 06/22/2022
• Supplement Dates FDA Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1