MAUDE Adverse Event Report: EXACTECH, INC. SHLDR GPS RVRS DRILL KIT; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	531-20-00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Periprosthetic fracture (4902)
Date of Event	12/13/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial reverse total shoulder replacement on the left side.Subsequently, the patient experienced a scapular fracture during implantation of devices.Drilling center cage for anatomic base plate, drill caught scapular vault and fractured glenoid at pin site.As a result, the patient was converted to rtsa intra-op without issue.No further impact to the patient was reported.No other information is available.
Additional Manufacturer Narrative
(d10) concomitant devices: 300-30-08 - equinoxe preserve stem 8mm: (b)(6).320-36-00 - 145-deg pe 36mm hum liner +0: (b)(6).320-10-00 - equinoxe rev adapter plate tray +0: (b)(6).320-31-36 - glenosphere, 36mm: (b)(6).320-35-07 - small sup/post aug glenoid plate, left: (b)(6).320-15-05 - eq rev locking screw: (b)(6).The instrument will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: h6, h11.The following sections were corrected: a2, b1, h6.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 review of complaint history determined that no further action is required as no trends were identified.A definitive root cause was unable to be determined; however, may have resulted from a patient condition or high forces during broaching, reaming, exposure, or retraction.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: SHLDR GPS RVRS DRILL KIT
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: goeff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 22613389
• Report Number: 1038671-2025-02598
• Device Sequence Number: 12108449
• Product Code: OLO
• UDI-Device Identifier: 10885862319272
• UDI-Public: 10885862319272
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K173372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 531-20-00
• 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: 07/11/2025
• Supplement Date Received by Manufacturer: 09/12/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2021
• 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: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Race: White