MAUDE Adverse Event Report: TORNIER INC AEQ. PERFORM+ KEELED OSTEOTOME AND PUNCH HANDLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	MWH744
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
During primary left anatomic shoulder replacement, surgeon was preparing the glenoid surface to receive a perform + left small 15 deg poly implant.Procedure had proceeded without incident, until the step to utilize the keeled osteotome and punch, which attaches on to the handle in instruments.The handle was found to be broken.The locking sleeve was completely separate to the main handle shaft.Attempts to reattach the sleeve onto the handle so the osteotome / punch can be locked to the handle, proved fruitless.In the end, the surgeon first placed the osteotome (over the guide wire still insitu) into the semi-prepared "keel hole", then placed the handle on to the end of the osteotome and impacted the osteotome.With the handle not attached to the osteotome, the only way to remove the osteotome, was grabbing it with a pair of heavy pliers, and hitting the pliers with a mallet to back it out.This process was repeated for the punch.The surgeon was happy that the keel-hole was adequately prepared (the trial implant seated home fully when inserted into the glenoid), but the surgeon was concerned about possible damage to the glenoid surface / vault, when using the mallet / pliers to remove the osteotome / punch.
Additional Manufacturer Narrative
Correction - please refer d9 product available to stryker.The reported event could be confirmed, since the product was not returned for evaluation however based on the provided image the product matches the alleged failure mode.The device inspection revealed the following: visual inspection: a device inspection was not possible since the affected device was not returned, however based on the provided images it was observed that the keeled punch handle lock nut came out of the handle shaft.The stop ring seems to be intact to the shaft as intended.Few blood marks are also visible on the handle.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.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
During primary left anatomic shoulder replacement, surgeon was preparing the glenoid surface to receive a perform + left small 15deg poly implant.Procedure had proceeded without incident, until the step to utilize the keeled osteotome and punch, which attaches on to the handle in instruments.The handle was found to be broken.The locking sleeve was completely separate to the main handle shaft.Attempts to reattach the sleeve onto the handle so the osteotome / punch can be locked to the handle, proved fruitless.In the end, the surgeon first placed the osteotome (over the guide wire still insitu) into the semi-prepared "keel hole", then placed the handle on to the end of the osteotome, and impacted the osteotome.With the handle not attached to the osteotome, the only way to remove the osteotome, was grabbing it with a pair of heavy pliers, and hitting the pliers with a mallet to back it out.This process was repeated for the punch.The surgeon was happy that the keel-hole was adequately prepared (the trial implant seated home fully when inserted into the glenoid), but the surgeon was concerned about possible damage to the glenoid surface / vault, when using the mallet / pliers to remove the osteotome / punch.

• Brand Name: AEQ. PERFORM+ KEELED OSTEOTOME AND PUNCH HANDLE
• 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21878264
• Report Number: 0001649390-2025-00262
• Device Sequence Number: 7865409
• Product Code: LXH
• UDI-Device Identifier: 00846832071654
• UDI-Public: (01)00846832071654(11)220324(10)DP0322062
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2025

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: MWH744
• Device Lot Number: DP0322062
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2025
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/24/2022
• 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 Sex: Female