MAUDE Adverse Event Report: ARTHREX, INC. DYNANITE® STAPLE DRL BT, CAL, 1.6, REUSE; BIT, DRILL

Model Number	DYNANITE® STAPLE DRL BT, CAL, 1.6, REUSE
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an akin surgery it was difficult to move the drill through the drill guide.However the surgery was finished successfully with the same device.After the surgery it was noticed that the drill is damaged and showed signs of abrasion.According to the surgeon there was no harm for patient, operator or third party reported.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
The complaint is confirmed due to the abrasion marks identified.(1) unpackaged ar-8717d-01-ru was received for evaluation.Visual inspection noted circumferential abrasion marks on the device's shoulder.The device was inserted in the accompanying ar-8717g-01 drill guide and it was able to be moved freely on 3 drill guides holes, except one, in which it was noted that one of the circumferential teeth were bent.The shoulder diameter was measured with a digital micrometer.The diameter measurement was.121, within the specification of.120 +-.002.The direct cause for the abrasion marks is attributed to usage of the drill with a damaged drill guide.Since the condition of the device prior to the procedure is unknown, the root cause remains undetermined.A potential cause for the bent circumferential tooth is damage incurred by dropping the device, impact with another device, or excessive forces applied during use.

• Brand Name: DYNANITE® STAPLE DRL BT, CAL, 1.6, REUSE
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 15804018
• Report Number: 1220246-2022-05765
• Device Sequence Number: 17518197
• Product Code: HTW
• UDI-Device Identifier: 00888867326163
• UDI-Public: 00888867326163
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2023

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: DYNANITE® STAPLE DRL BT, CAL, 1.6, REUSE
• Device Catalogue Number: AR-8717D-01-RU
• Device Lot Number: 032116
• 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: 10/28/2022
• Supplement Date Received by Manufacturer: 10/28/2022
• Initial Report FDA Received Date: 11/16/2022
• Supplement Report FDA Received Date: 01/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown