MAUDE Adverse Event Report: ARTHREX, INC. GAP DRILL GUIDE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	GAP DRILL GUIDE
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2021
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that during a meniscotibial capsule re-fixation surgery the device broke off while aligning the device during the placement of the third anchor.No broken parts remained inside the patient.The device worked as intended for the first two anchors.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with the same device.The third anchor was placed successfully by aligning the device in a freehand way.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Complaint confirmed.Visual evaluation identified that the distal tip of the device broke off.The root cause of the reported failure mode is undetermined.However, the most likely probable cause is applying excessive mechanical forces upon insertion.

• Brand Name: GAP DRILL GUIDE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12434078
• Report Number: 1220246-2021-03603
• Device Sequence Number: 4739484
• Product Code: LXH
• UDI-Device Identifier: 00888867307506
• UDI-Public: 00888867307506
• 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,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2021

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 Expiration Date: 08/31/2025
• Device Model Number: GAP DRILL GUIDE
• Device Catalogue Number: AR-5875G
• Device Lot Number: 11797140
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/18/2021
• Supplement Date Received by Manufacturer: 08/18/2021
• Initial Report FDA Received Date: 09/07/2021
• Supplement Report FDA Received Date: 10/28/2021
• Patient Sequence Number: 1