MAUDE Adverse Event Report: EXACTECH, INC. STM PROTECTOR; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number	301-07-20
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 300-60-02 - stemless humeral comp laser cage, size 2: b262600.310-62-44 - stemless humeral head 44mm x 14mm x beta: a991142.314-24-33 - laser cage glenoid m, 8 post aug, right: b337447.315-35-00 - glnd kwire: b441939.319-01-32 - steinmann pin sterile 3.2mm x 178mm: b363437.321-52-10 - 3.2mm k-wire, thd, short 2 k-wires per pack: b363821.531-78-20 - shouldr gps hex pins kit: b132145.A10012 - gps implant kit v2: 09008824150.The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/technique.A definitive root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
The patient underwent an initial shoulder arthroplasty.Following the procedure, it was discovered that a humeral cut protection plate had been inadvertently retained within the surgical site.The retained object caused a laceration of the subscapularis tendon.As a result, the patient required a subsequent surgical procedure for removal of the retained foreign body and repair of the injured tendon.No further information is available.

• Brand Name: STM PROTECTOR
• Common Device Name: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 24501135
• Report Number: 1038671-2026-00221
• Device Sequence Number: 10115360
• Product Code: HSD
• UDI-Device Identifier: 10885862079718
• UDI-Public: 10885862079718
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/03/2026

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: 301-07-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 03/03/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 63 YR
• Patient Sex: Unknown