MAUDE Adverse Event Report: TORNIER INC PERFORM REVERSED PERIPHERAL & SPHERE SCREWDRIVER BIT T20; BIT, SURGICAL

Model Number MWJ127

Device Problems Break (1069); Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/24/2023

Event Type  malfunction  

Event Description

It was reported that the patient presented during primary procedure.During the procedure the central screw of the perform reverse glenosphere was engaged with the baseplate and the surgeon was continuing to tighten the screw to ensure fixation.Upon turning the driver the last time the end of the screwdriver snapped off within the screw head of the glenosphere.Several attempts were used by the surgeon to retrieve the end of the screwdriver that was lodged into the glenosphere.All attempts were unsuccessful.During these attempts, a dental pick and osteotome tips were also broken within the glenosphere central screw/baseplate junction.Ultimately the surgeon was unable to retrieve any of these pieces.X-ray was performed and the surgeon was unable to see these pieces within the shoulder.Surgeon was happy to continue with surgery and the procedure was completed with no further adverse effects.There was a surgical delay of 30 minutes.The surgery was completed successfully following the incident.

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Manufacturer Narrative

The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: visual inspection: the visual inspection of the returned device reveals breakage at the distal end of the device.The breakage patterns are shiny and planar in appearance indicative of brittle fracture.The fragmented part of the device was not available for inspection.Furthermore, a hardness test according to rockwell hardness tester ref# (b)(4) on the returned item indicates the material being in accordance: hardness test 1: 59.0/ hardness test 2: 58.8/ hardness test 3: 59.0.Observed hardness: 58.93 hrc required hardness: 58-59 hrc.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on investigation, the root cause was attributed to a combination of user and wear related error.The failure was caused by application high impact torsional forces with combination of frequent usage over the time (2018).If any further information is provided, the complaint report will be updated.

Event Description

It was reported that the patient presented during primary procedure.During the procedure the central screw of the perform reverse glenosphere was engaged with the baseplate and the surgeon was continuing to tighten the screw to ensure fixation.Upon turning the driver the last time the end of the screwdriver snapped off within the screw head of the glenosphere.Several attempts were used by the surgeon to retrieve the end of the screwdriver that was lodged into the glenosphere.All attempts were unsuccessful.During these attempts, a dental pick and osteotome tips were also broken within the glenosphere central screw/baseplate junction.Ultimately the surgeon was unable to retrieve any of these pieces.X-ray was performed and the surgeon was unable to see these pieces within the shoulder.Surgeon was happy to continue with surgery and the procedure was completed with no further adverse effects.There was a surgical delay of 30 minutes.The surgery was completed successfully following the incident.

• Brand Name: PERFORM REVERSED PERIPHERAL & SPHERE SCREWDRIVER BIT T20
• Type of Device: BIT, SURGICAL
• 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: 16961402
• MDR Text Key: 315551751
• Report Number: 0001649390-2023-00104
• Device Sequence Number: 1
• Product Code: GFG
• UDI-Device Identifier: 00846832062492
• UDI-Public: 00846832062492
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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: 09/27/2023

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: Health Professional
• Device Model Number: MWJ127
• Device Catalogue Number: MWJ127
• Device Lot Number: CR0318088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/24/2023
• Initial Date FDA Received: 05/19/2023
• Supplement Dates Manufacturer Received: 09/06/2023
• Supplement Dates FDA Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2018
• 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
• Patient Sex: Female