MAUDE Adverse Event Report: SYMMETRY MEDICAL MULTIGRASPER; ARTHROSCOPY

Model Number N/A

Device Problem Bent (1059)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

Instrument was manufactured in 2010 and shows sign of use.No discrepancies noted in device history record.Would appear that the instrument was subjected to excessive force during use.It is noted in the complaint that this event did not cause any delay or adverse effects and the instrument was used to complete the procedure.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation: under care and handling of instruments: ¿surgical instruments and instrument cases are susceptible to damage for a variety of reasons including prolonged use, misuse, rough or improper handling.¿ if any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.(b)(4).

Event Description

It was reported that patient underwent a shoulder procedure on an unknown date.During the procedure the multigrasper bent; however, there were reportedly no adverse effects in the procedure as a result.

• Brand Name: MULTIGRASPER
• Type of Device: ARTHROSCOPY
• Manufacturer (Section D): SYMMETRY MEDICAL; 15 colebrook blvd.; whitman MA 02382 9170
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell dr.; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6903658
• MDR Text Key: 88150334
• Report Number: 0001825034-2017-07429
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 910063
• Device Lot Number: L658746
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2014
• Date Manufacturer Received: 10/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1