MAUDE Adverse Event Report: ARTHREX, INC. SCRWDRV,CANN FOR BIO INT. SCRW; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	SCRWDRV,CANN FOR BIO INT. SCRW
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/27/2019
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that the arthrex ar-1386 screwdriver was used during anterior cruciate ligament surgery.During insertion of the screw, the tip of the screwdriver has broken off inside the screw.It was not possible for the surgeon to remove the tip.The patient is very young.The parents and the patient were informed about the incident.The surgery was still completed successfully.No further information received.
Additional Manufacturer Narrative
Complaint confirmed, the tip of the device broke off near the shoulder.Likely causes include prying/leveraging the device during use, misaligned insertion, improper bone prep, continually applying torque when the device is not advancing and/or fully seated.The stripped anodization is likely due to repeated use and cleaning cycles.

• Brand Name: SCRWDRV,CANN FOR BIO INT. SCRW
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9519620
• Report Number: 1220246-2019-01539
• Device Sequence Number: 491534
• Product Code: LXH
• UDI-Device Identifier: 00888867015425
• UDI-Public: 00888867015425
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2020

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: SCRWDRV,CANN FOR BIO INT. SCRW
• Device Catalogue Number: AR-1386
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/10/2019
• Supplement Date Received by Manufacturer: 12/10/2019
• Initial Report FDA Received Date: 12/26/2019
• Supplement Report FDA Received Date: 02/13/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other