MAUDE Adverse Event Report: TORNIER INC PERFORM HUMERAL SYSTEM; SHOULDER JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS

Catalog Number MWM005

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/12/2021

Event Type  malfunction  

Manufacturer Narrative

The device was not returned at the time of this report.If additional information becomes available, it will be provided on a supplemental report.

Event Description

It was reported that one of the spikes from the size 3 cut protector broke off during use in shoulder surgery.The surgeon verified that the broken portion was in the patient and could not remove the portion from the humeral canal.No additional complications were reported.

Event Description

It was reported that one of the spikes from the size 3 cut protector broke off during use in shoulder surgery.The surgeon verified that the broken portion was in the patient and could not remove the portion from the humeral canal.No additional complications were reported.

Manufacturer Narrative

The reported event could be confirmed.The device was returned for evaluation and found to be in the condition stated in the event description.The device inspection revealed the following: visual inspection: the received device shows signs of usage evidenced by the scratches and scuffs on the underside of the device.The inspection also confirms separation of one of the spikes that hold the cut protector in place on the resected humeral bone.Based on investigation, the root cause is attributed to wear due to the intended use of the device.The spikes of the device are laser welded on the flat plate.This device is subject to numerous impaction; and pulling forces during it¿s use.If the user used a "joysticking" motion when removing the device from the resected humerus it could likely lead to the breakage noted in this complaint.A review of the device history record for the reported lot did not indicate any abnormalities.A review of the labeling did not indicate any abnormalities.If any further information is provided, the complaint report will be updated.

• Brand Name: PERFORM HUMERAL SYSTEM
• Type of Device: SHOULDER JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer Contact: nathe hendricks ; 1023 cherry rd; memphis, TN 38117 ; 9014516318
• MDR Report Key: 11952834
• MDR Text Key: 262264702
• Report Number: 3004983210-2021-00051
• Device Sequence Number: 1
• Product Code: PAO
• UDI-Device Identifier: 00846832082810
• UDI-Public: 00846832082810
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201315
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MWM005
• Device Lot Number: FF0220287
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2020
• 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