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	09/04/2019
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 requested/is expected but has not been 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 tip of screwdriver broke inside the screw during implantation.Update 10-sept-2019: an anterior cruciate ligament (acl) procedure was performed.The broken piece remained in the screw inside patient.The surgery was finished successfully with the same device was used anyway.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Complaint confirmed, the entire drive feature was found to have broken off from the device.The device also appeared to be worn, with faded and scratched anodization and laser markings.The most likely cause of tip breaking is prying and/or leveraging the device during use.The most likely cause of scratching and anodization fading is wear and tear, repeated use of the device.

• 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: 9141367
• Report Number: 1220246-2019-01334
• Device Sequence Number: 2733709
• Product Code: LXH
• UDI-Device Identifier: 00888867015425
• UDI-Public: 00888867015425
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2019

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
• Device Lot Number: 251495
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/10/2019
• Supplement Date Received by Manufacturer: 09/10/2019
• Initial Report FDA Received Date: 10/01/2019
• Supplement Report FDA Received Date: 10/10/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other