MAUDE Adverse Event Report: INCIPIO DEVICES OFFSET CUP IMPACTOR - 3/8-16 INTERFACE

Catalog Number	50341105
Medical Device Problem Codes	Crack (1135); Nonstandard Device (1420); Solder Joint Fracture (2324); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned.Photographs of the device confirmed the reported complaint.The tig weld has fractured resulting in the strike plate separating completely from the assembly.Manufacturing records were reviewed and there were no anomalies or non-conformances raised.However, photographs provided for previous complaints appeared to show an anomaly with regards to the tig weld quality.Investigation demonstrated that the issue was caused by inadequate operator technique during the tig weld operation.Qualification records for the welders are on record.External training courses have been scheduled.The effectiveness of the training will be tested by the external training firm.Owing to the high likelihood of failure for this product lot, a recall for this product lot has been initiated.No patient harm resulted from this device anomaly.
Event or Problem Description
It was reported that during a thr surgery, upon impaction of the cup, the strike plate of one (1) incipio offset cup impactor completely broke off and fell on the floor.The procedure resumed, after a non-significant delay, using a back-up device.No injury was reported as a consequence of this issue.

• Brand Name: OFFSET CUP IMPACTOR - 3/8-16 INTERFACE
• Common Device Name: OFFSET CUP IMPACTOR
• Manufacturer (Section D): INCIPIO DEVICES; avenue des paquiers 16; st. blaise, 2072 ; SZ 2072
• Manufacturer Contact: chris taylor ; avenue des paquiers 16; st. blaise, 2072 ; SZ 2072
• MDR Report Key: 20914633
• Report Number: 3013223655-2024-00002
• Device Sequence Number: 20977806
• Product Code: HWA
• UDI-Device Identifier: 07630055304735
• UDI-Public: 07630055304735
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 11/05/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 50341105
• Device Lot Number: 24A0087
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2024
• Initial Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/05/2024
• 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: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 95653
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown