MAUDE Adverse Event Report: EXACTECH, INC. OFFSET CUP IMPACTOR THREADED LOCKING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	OFFSET CUP IMPACTOR THREADED LOCKING
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, alteon cup was inserted and upon removal of the insertion handle it was noticed that it had broken.Cup was well fixed and surgery proceeded without delay.There were no fragments, parts, or pieces that fall into the patient.Images & x-rays unavailable.Patient was last known to be in stable condition following the event.The device is available for evaluation.
Additional Manufacturer Narrative
After further review of additional information received the following sections d9, g3, g6, h2, h3 and h6 have been updated accordingly.(h3) the broken cup impactor reported may have been the result of weld degradation and/or an insufficient weld, which resulted in separation of the upper and lower body subcomponents and the inability of the device to function as intended.The most probable root cause associated with the reported event of ¿broken / non-functional¿ is associated with undesired damage or breakage in a solder joint of materials used in the device construction.
Additional Manufacturer Narrative
Upon reassessment of the reported event, it was determined that the event did not involve a death or serious injury nor would be likely to cause or contribute to a death or serious injury if the reported malfunction were to recur.As a result, this complaint event is no longer considered reportable by exactech and this report may be disregarded.

• Brand Name: OFFSET CUP IMPACTOR THREADED LOCKING
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15696488
• Report Number: 1038671-2022-01369
• Device Sequence Number: 20538629
• Product Code: LXH
• UDI-Device Identifier: 10885862520623
• UDI-Public: 10885862520623
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/22/2026

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 Model Number: OFFSET CUP IMPACTOR THREADED LOCKING
• Device Catalogue Number: 181-02-01
• Device Lot Number: 271135001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2022
• Supplement Date Received by Manufacturer: 06/06/2023; 04/14/2026
• Initial Report FDA Received Date: 10/29/2022
• Supplement Report FDA Received Date: 07/05/2023; 04/22/2026
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown