MAUDE Adverse Event Report: EXACTECH, INC. MOD CANNULATED PEG DRILL; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Model Number	N/A
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, the surgeon was drilling over the k-wire and the k-wire was bent but no one saw and the drill snapped when it was being drilled of the bent part.Fragments, parts or pieces fell into the patient and were removed.After the drill broke everything was removed and confirmed by x-ray.No adverse events as a result of the surgical delay/prolongation.After everything was removed we moved on with surgery.The patient was last known to be in stable condition following the event.No other patient information/medical history reported.The device is not returning as it was a sharp and was thrown out.
Additional Manufacturer Narrative
H3: the fractured ergo cannulated peg drill reported was likely due to passing the drill bit over a bent k-wire, as stated in the experience report, which led to metal binding between the two devices and resulted in ultimate fracture of the drill bit when passed over the bent portion of the k-wire.As previously stated, a contributing factor to device fracture may have be due to the depth of the drill bit flutes if the drill bit were to bind with the k-wire.However, this cannot be confirmed as the devices were not returned for evaluation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The fractured ergo cannulated peg drill reported was likely due to passing the drill bit over a bent k-wire, as stated in the experience report, which led to metal binding between the two devices and resulted in ultimate fracture of the drill bit when passed over the bent portion of the k-wire.As previously stated, a contributing factor to device fracture may have been due to the depth of the drill bit flutes if the drill bit were to bind with the k-wire.However, this cannot be confirmed as the devices were not returned for evaluation.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: MOD CANNULATED PEG DRILL
• 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, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15213928
• Report Number: 1038671-2022-00910
• Device Sequence Number: 5851552
• Product Code: HSD
• UDI-Device Identifier: 10885862558176
• UDI-Public: 10885862558176
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 01/08/2025

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 Model Number: N/A
• Device Catalogue Number: 315-52-63
• Device Lot Number: 144604022
• 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: 07/22/2022
• Supplement Date Received by Manufacturer: 03/09/2023; 01/07/2025
• Initial Report FDA Received Date: 08/11/2022
• Supplement Report FDA Received Date: 03/28/2023; 01/08/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male