MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP SWVLK 3.5X 15.8MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	BIO-COMP SWVLK 3.5X 15.8MM
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/25/2018
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 returned for evaluation.The cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that during a mpfl - patella stabilisation.The screw broke at the first turn.The remaining part still lies in the soft tissue and could not be recovered.A swivelock 3.5 was used again.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.Updated information obtained (b)(6) 2018: the fragment was not retrieved, it is located in the soft tissue area of the quadriceps tendon and can not move.No x-ray is available.According to the doctor no impairment or consequential damages is foreseeable.
Additional Manufacturer Narrative
Complaint confirmed.Visual evaluation revealed that the bio-composite screw and the peek eyelet were not returned.Only swivelock driver was returned.Complainant's event is most likely caused by improper bone preparation.

• Brand Name: BIO-COMP SWVLK 3.5X 15.8MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8083807
• Report Number: 1220246-2018-00750
• Device Sequence Number: 295733
• Product Code: MAI
• UDI-Device Identifier: 00888867283626
• UDI-Public: 00888867283626
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2019

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 Expiration Date: 07/31/2020
• Device Model Number: BIO-COMP SWVLK 3.5X 15.8MM
• Device Catalogue Number: AR-2325BCC-1
• Device Lot Number: 10233376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2019
• Initial Date Received by Manufacturer: 10/30/2018
• Supplement Date Received by Manufacturer: 10/30/2018
• Initial Report FDA Received Date: 11/19/2018
• Supplement Report FDA Received Date: 02/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other