MAUDE Adverse Event Report: TORNIER INC PERFORM CUT PROTECTOR SIZE 2; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	MWM004
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The surgeon performed a reverse shoulder arthroplasty.The case went as planned and the post-op x-rays that were performed in the operating room looked normal.The surgeon requested instruments be delivered for a revision surgery due to a perform humeral cut protector that was retained in the patient post operatively.
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
The surgeon performed a reverse shoulder arthroplasty.The case went as planned and the post-op x-rays that were performed in the o.R.Looked normal.The surgeon requested instruments be delivered for a revision surgery due to a perform humeral cut protector that was retained in the patient post operatively.
Additional Manufacturer Narrative
Correction h6 method code, d9/h3 the reported event could be confirmed, since a medical expert reviewed received x-rays and confirmed the retention of the perform cut protector size 2 post operatively.Since data was provided, the opinion of a medical expert was sought and stated as follows: "the x-ray¿s show the perform reversed shoulder prothesis, and confirms the presence of the perform cut protector situated in the patient¿s shoulder joint at the postero-inferior region of the glenoid, possibly contacting the glenosphere in that area.Although instrument checks per protocol and intra-operative x-ray images should prevent this from happening, it is work by humans, and unfortunately these things happen." the device inspection revealed the following: a visual inspection found the device to be in good condition.No deficiences were able to be detected.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by user error.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the complaint report will be updated.

• Brand Name: PERFORM CUT PROTECTOR SIZE 2
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15266932
• Report Number: 0001649390-2022-00053
• Device Sequence Number: 6599484
• Product Code: LXH
• UDI-Device Identifier: 00846832082858
• UDI-Public: 00846832082858
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: MWM004
• Device Catalogue Number: MWM004
• Device Lot Number: FF0121168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2022
• Supplement Date Received by Manufacturer: 09/27/2022
• Initial Report FDA Received Date: 08/22/2022
• Supplement Report FDA Received Date: 10/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2021
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male