MAUDE Adverse Event Report: ARTHREX, INC. BIO-COM INTERFERENCE SCREW, TAPERED TIP; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	BIO-COM INTERFERENCE SCREW, TAPERED TIP
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint confirmed.The evaluation confirmed the screw had broken at about the fourth thread from the proximal end.The tip was not received.The broken end was flattened and misshapen and there was an additional crack across the thread proximal to the break.Dimensional testing could not be performed due condition of the returned device.This type of damage is typically caused by not inserting the implant co-axial to the bone tunnel, prying or leveraging while still loaded, improper bone preparation or flexing the joint during insertion.
Event or Problem Description
It was reported that during a deepening tracheloplasty with mpfl procedure, the gracilis tendon was fixed femorally in the tunnel with a bio interference screw (tapered tip, 6 x 23 mm).When screwing in, part of the screw has broken off.The front part is still in the patient and, according to the doctor, offers sufficient stability to fix the tendon.The other part of the broken screw is retrieved.Surgery was completed successfully with the same device because surgeon confirms that it has enough fixation.According to the surgeon there was no harm for patient, user or third party.

• Brand Name: BIO-COM INTERFERENCE SCREW, TAPERED TIP
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7845831
• Report Number: 1220246-2018-00624
• Device Sequence Number: 1338129
• Product Code: MAI
• UDI-Device Identifier: 00888867014008
• UDI-Public: 00888867014008
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K071176
• 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
• Report Date (Section B): 09/05/2018

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: 03/31/2020
• Device Model Number: BIO-COM INTERFERENCE SCREW, TAPERED TIP
• Device Catalogue Number: AR-1360C
• Device Lot Number: 10201178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2018
• Initial Report FDA Received Date: 09/05/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other