MAUDE Adverse Event Report: G. HIPP AND SOHN SOUDRY LOOSE BODY GRASPER

Model Number 1769

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/07/2015

Event Type  malfunction  

Event Description

Customer ((b)(6) health) reported that the tooth of the soudry loose tissue grasper broke off while in use and is inside the patient.An additional part number, purchased at the same time was subjected to pressure.Its tooth also became loose.Once received at innomed, the items were visually inspected to check the security of the tooth pin and no faults were found.The tooth weld did not have any cracks and the polished side had sufficient material to preserve the security of the pin.Although no issues were identified with the tooth pin's security, it was determined that the items would be forwarded to the vendor to have the new weld process applied.The item was received and subjected to visual inspection.No issues were identified.The intended use of the soudry loose body grasper is to aid in the removal of soft tissue loose bodies in arthroscopy and open procedures.The instrument was tested by applying it on various type rubbers, foam and cardboard to simulate the removal of soft tissue.No break in the weld was experienced when used to grip, pull, and twist the material.The instrument was also tested by applying it to metal and wood to simulate removal of hard tissue.It was noticed that upon gripping the aforementioned material, the tooth became stuck without engagement of the secondary teeth.This in turn caused the tooth not to be able to rotate, as it should when using it in a twisting motion.Without the secondary teeth being engaged, too much stress is placed on the tooth and results in breakage at the weld.It is safe to conclude that the break which occurred during surgery resulted from the instrument being employed outside of its intended use.

• Brand Name: SOUDRY LOOSE BODY GRASPER
• Type of Device: GRASPER
• Manufacturer (Section D): G. HIPP AND SOHN; carl benz-str. 1, 78579; neuhausen ob eck, ; GM
• MDR Report Key: 5335581
• MDR Text Key: 34738351
• Report Number: 1833053-2015-00002
• Device Sequence Number: 1
• Product Code: HTX
• UDI-Device Identifier: 00840277117304
• UDI-Public: 00840277117304
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/30/2015,12/28/2015

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: No Information
• Device Model Number: 1769
• Device Catalogue Number: 1769
• Device Lot Number: 1214GH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2015
• Was the Report Sent to FDA?: Yes
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/30/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/30/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1