MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; RESURF HEAD IMPACTOR

Catalog Number	313-07-07
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, during a left total shoulder arthroscopy on a (b)(6) y/o male patient, the impactor broke when hit by the mallet.Piece that was broken off was removed.All pieces retrieved.X-rays taken - clear.No patient harm.No change in procedure.
Additional Manufacturer Narrative
Section h10: (h3) the broken device reported was likely the result of experiencing impaction forces during surgical use which led to crack initiation, propagation, and ultimate failure.However, this cannot be confirmed because the component was not returned for evaluation.
Additional Manufacturer Narrative
Section h11: *the following sections have corrected information: (g4) initial awareness date in initial submission should have been 17-nov-2020.

• Brand Name: EQUINOXE
• Common Device Name: RESURF HEAD IMPACTOR
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 10905163
• Report Number: 1038671-2020-00628
• Device Sequence Number: 11378933
• Product Code: LXH
• UDI-Device Identifier: 10885862252241
• UDI-Public: 10885862252241
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/14/2022

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: 313-07-07
• Device Lot Number: 103095004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/01/2020
• Supplement Date Received by Manufacturer: 11/17/2020; 03/24/2022
• Initial Report FDA Received Date: 11/25/2020
• Supplement Report FDA Received Date: 12/16/2020; 04/14/2022
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male