MAUDE Adverse Event Report: TORNIER INC PERFORM REVERSED CENTRAL SCREWDRILL 6.5MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	MWJ111
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "the patient was undergoing a perform stem and perform reversed total shoulder prosthesis, had a high bone density and a sclerotic glenoid, which had previously twisted the threaded spindle, for glenoid aiming guidance.During drilling of the central screw of the perform reversed baseplate, the 6.5-diameter wire, ref mwj111, broke off, leaving 2/3 of it in the patient's glenoid.The surgeon was unable to remove the debris, and inserted a short 7mm stud in place of the 6.5x25 central screw initially chosen.The operation was completed without difficulty.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.More detailed information about the complaint event as well as the affected device must be available in order to determine the exact root cause of the complaint event.If device is returned or any further information is provided, the investigation report will be reassessed.H3 other text: device disposition unknown.
Event or Problem Description
As reported: "the patient was undergoing a perform stem and perform reversed total shoulder prosthesis, had a high bone density and a sclerotic glenoid, which had previously twisted the threaded spindle, for glenoid aiming guidance.During drilling of the central screw of the perform reversed baseplate, the 6.5-diameter wire, ref mwj111, broke off, leaving 2/3 of it in the patient's glenoid.The surgeon was unable to remove the debris, and inserted a short 7mm stud in place of the 6.5x25 central screw initially chosen.The operation was completed without difficulty.".

• Brand Name: PERFORM REVERSED CENTRAL SCREWDRILL 6.5MM
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• 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: 18047188
• Report Number: 0001649390-2023-00295
• Device Sequence Number: 15464264
• Product Code: HWE
• UDI-Device Identifier: 00846832062348
• UDI-Public: 00846832062348
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2023

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MWJ111
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/03/2023
• Supplement Date Received by Manufacturer: 11/23/2023
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 12/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 130 KG