MAUDE Adverse Event Report: INNOMED INC. SUREGRIP SOFT TISSUE RONGEUR; PLIERS

Model Number	3645-02
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Report mw5113547 was received at innomed, inc from the center for devices and radiological health on 12/12/2022 with the event description documented in describe event or problem.Innomed contacted the initial reporter via email on the day the device was received and requested to have it returned to evaluate the described condition.Innomed will follow up when the device has been received and the evaluation has been completed.
Event or Problem Description
Pt.Had reverse total shoulder surgery.Surgery was completed and patient taken to pacu.The instruments for the case was taken to decontamination, where the spd employee washing the instrument noticed a piece missing from a pituitary rongeur.Physician responded that he saw the x-ray and the piece of metal.Noted shouldn't be a problem now.He plans to re x-ray at his post appointment to see if the piece had moved which was determined to be a piece of the pituitary rongeur.The patient was sent home, and it appears the small piece left in the shoulder should not be problem, but will be monitored on future appointments.
Event or Problem Description
Pt.Had reverse total shoulder surgery.Surgery was completed and patient taken to pacu.The instruments for the case was taken to decontamination, where the spd employee washing the instrument noticed a piece missing from a pituitary rongeur.Physician responded that he saw the x-ray and the piece of metal.Noted shouldn't be a problem now.He plans to re x-ray at his post appointment to see if the piece had moved which was determined to be a piece of the pituitary rongeur.The patient was sent home, and it appears the small piece left in the shoulder should not be problem, but will be monitored on future appointments.
Additional Manufacturer Narrative
The affected device was never returned to innomed for evaluation by the initial reporter.Innomed surveyed the capa and complaints database for this part and the described issue.No capas were issued.Three complaints were identified in the internal complaints database with this issue.In the first complaint, an investigation and a 5 why were performed to determine the root cause.Based on the determined root cause, the correction included changing from laser welding to stick welding.The latter was determined to be the more appropriate weld, as it ensured the best fit needed to keep the pin intake and immobile.This information was documented in ca# 249.Also documented were containment activities, and preventive measures.It was determined that the device in the second complaint had the same lot number as the device in first complaint.Therefore, it was not a repeat issue after correction was implemented.The aforementioned complaints were received at innomed in 2014 and 2015.In the third complaint, the customer never returned the device to innomed for inspection and evaluation.Innomed determined that the described issue occured after the corrective measure was implemented.The complaint was received in 2022.Innomed has not received a complaint regarding this device and its described issue in almost nine (9) years.Innomed also was unable to determine if the last complaint was user induced.This part will be monitored to determined if additional corrective measures are required.

• Brand Name: SUREGRIP SOFT TISSUE RONGEUR
• Common Device Name: PLIERS
• Manufacturer (Section D): INNOMED INC.; 103 estus drive; savannah GA 31404
• Manufacturer Contact: mr. wissner ; carl benz stasse 1; neuhausen ob eck, 78579 ; GM 78579
• MDR Report Key: 16053757
• Report Number: 1833053-2022-00005
• Device Sequence Number: 6218796
• Product Code: HTC
• UDI-Device Identifier: 00840277105943
• UDI-Public: 00840277105943
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2023

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: 3645-02
• Device Catalogue Number: 3645-02
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2022
• Supplement Date Received by Manufacturer: 12/12/2022
• Initial Report FDA Received Date: 12/27/2022
• Supplement Report FDA Received Date: 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown