MAUDE Adverse Event Report: ARTHREX, INC. HUMERAL SUTUREPLATE, 5-HOLE, TITANIUM; PLATE, FIXATION, BONE

Model Number	HUMERAL SUTUREPLATE, 5-HOLE, TITANIUM
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/18/2018
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 reported to have been discarded and was not returned for evaluation.The cause of the event could not be determined from the information available and without device evaluation.The part numbers of the screws which broke upon explanting, and whose tips remain in the patient, are unknown.Separate medwatch reports for those screws cannot be submitted without part numbers.The screws were reported to have been discarded at the facility.
Event or Problem Description
It was reported that during a proximal suture plate removal procedure, as the surgeon went to remove the screws, the screw tips on each screw became detached and remained in patients humerus.The surgeon did not attempt to retrieve the tips and no extra surgery is scheduled to remove the tips either.The patient condition was stable.Additional hardware was removed as well, however, the part and lot numbers are unknown.Additional information received 7/27/2018: the rep could not find out the date of the implant removal surgery.She just knew that the removal surgery was performed recently and the original implanted date is (b)(6) 2016.((b)(6) 2018 will be used as the event date).All related screws have been already discarded by hospital; therefore, part numbers could not be obtained.The implants were removed because the bone had healed.

• Brand Name: HUMERAL SUTUREPLATE, 5-HOLE, TITANIUM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7739145
• Report Number: 1220246-2018-00589
• Device Sequence Number: 13713190
• Product Code: HRS
• UDI-Device Identifier: 00888867016149
• UDI-Public: 00888867016149
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K041965
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/01/2018

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 Model Number: HUMERAL SUTUREPLATE, 5-HOLE, TITANIUM
• Device Catalogue Number: AR-14005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2018
• Initial Report FDA Received Date: 08/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1