MAUDE Adverse Event Report: ARTHREX INC. CANNULATED SCREW 3.75X 36MM FULLY THREADED; SCREW, FIXATION, BONE

Catalog Number	AR-7000-36FT
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Seizures (2063); Joint Dislocation (2374)
Date of Event	04/17/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation therefore the complainant's event could not be verified.Lot number was not provided so device history record review cannot be performed.The cause of the event could not be determined from the information available and without device evaluation.If additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
Alleged failure of an arthrex product was reported by the patient's attorney via a person injury complaint.No further information is available at time of initial report.Additional information obtained 1/11/2018: op report (b)(6) 2014 records noted that the patient has a history of dislocations of his shoulder which was previously treated with an arthroscopic capsulorrhaphy.Patient had ongoing evidence of instability of the shoulder.On (b)(6) 2014 a right open latarjet reconstruction procedure was performed on patient's right shoulder using a congruent arc technique.Medical records dated (b)(6) 2015 note that during the post-operative period, there was a failure of the hardware and a non-union of the congruent arc reconstruction.Records note the patient may have experienced a seizure when the failure of the hardware occurred.A revision congruent arc reconstruction with a possible iliac crest bone graft was performed on (b)(6) 2015.The original surgeon also performed the revision procedure.The surgeon identified the remnant of the coracoid process, which was used in the anterior arc reconstruction.It was noted to be small and it had a fracture through the superior screw hole.The screws were removed out of the bone graft fragment.The ends of the screws were identified and the surgeon used an easy-out bit to remove the screws.Records noted that patient had requested the screws be returned to him after cleaning.Procedure was completed using a graft and three 4.0 mm ao screws.The specific part number or implant log has not been provided.Based on a picture of the explanted screws placed next to a ruler and the description of the procedure from the op report the most likely part number for the two explanted screws is ar-7000-36ft, cannulated screw 3.75 x 36 mm fully threaded.
Additional Manufacturer Narrative
No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation therefore the complainant's event could not be verified.Device history record review revealed nothing relevant to the event.The cause of the event could not be determined from the information available and without device evaluation.If additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
Alleged failure of an arthrex product was reported by the patient's attorney via a person injury complaint.No further information is available at time of initial report.Additional information obtained 1/11/2018: op report (b)(6) 2014 records noted that the patient has a history of dislocations of his shoulder which was previously treated with an arthroscopic capsulorrhaphy.Patient had ongoing evidence of instability of the shoulder.On (b)(6) 2014 a right open latarjet reconstruction procedure was performed on patient's right shoulder using a congruent arc technique.Medical records dated (b)(6) 2015 note that during the post-operative period, there was a failure of the hardware and a non-union of the congruent arc reconstruction.Records note the patient may have experienced a seizure when the failure of the hardware occurred.A revision congruent arc reconstruction with a possible iliac crest bone graft was performed on (b)(6) 2015.The original surgeon also performed the revision procedure.The surgeon identified the remnant of the coracoid process, which was used in the anterior arc reconstruction.It was noted to be small and it had a fracture through the superior screw hole.The screws were removed out of the bone graft fragment.The ends of the screws were identified and the surgeon used an easy-out bit to remove the screws.Records noted that patient had requested the screws be returned to him after cleaning.Procedure was completed using a graft and three 4.0mm ao screws.The specific part number or implant log has not been provided.Based on a picture of the explanted screws placed next to a ruler and the description of the procedure from the op report the most likely part number for the two explanted screws is ar-7000-36ft, cannulated screw 3.75 x 36mm fully threaded.Patient is a male, (b)(6).Additional information obtained 2/21/2018: sales invoice received which confirms that the patient's original (b)(6) 2014 implants, which were explanted on (b)(6) 2015, were as follows: ar-70000-36ft, lot 965672 ((b)(4)) qty 1 and ar-7000-34ft, lot b11744 ((b)(4)) qty 1.

• Brand Name: CANNULATED SCREW 3.75X 36MM FULLY THREADED
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7241450
• Report Number: 1220246-2018-00024
• Device Sequence Number: 987121
• Product Code: HWC
• UDI-Device Identifier: 00888867041080
• UDI-Public: 00888867041080
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K103705
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2018

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 Catalogue Number: AR-7000-36FT
• Device Lot Number: 965672
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/11/2018
• Supplement Date Received by Manufacturer: 02/21/2018
• Initial Report FDA Received Date: 02/05/2018
• Supplement Report FDA Received Date: 03/12/2018
• 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
• Patient Age: 25 YR