MAUDE Adverse Event Report: ARTHREX, INC. #5 FIBERWIRE W/ NEEDLES FOR SUTUREPLATE; SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	#5 FIBERWIRE W/ NEEDLES FOR SUTUREPLATE
Health Effect - Clinical Codes	Skin Discoloration (2074); Metal Related Pathology (4530)
Date of Event	06/08/2015
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 not 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 due to a metallosis the shoulder and the arm of the patient turned black.The surgery which led to the reported event was a shoulder prosthesis which was performed on the (b)(6) 2015.According to the customer arthrex devices were implanted during the initial surgery in 2015.Currently it is not known in which hospital the initial surgery took place.Therefore no further information about the detailed incident and the used arthrex part numbers are currently available.Update 12-oct-2020: initially the lot numbers which were affected were not provided however further information were now provided that the following parts were used during the initial surgery 2015: ar-9120-01, lot: 140113110.Ar-9145-30, lot: 140123108.Ar-9504s-04, lot: 2501212801.Ar 9165-15, lot: 140103207.Ar-9145-30, lot: 2501417704.Ar-9502-36cpc, lot: 140120310.Ar -9501-07cpc, lot: 2501215303.Ar-9503s-03, lot: 140104307.Ar-9555-15, lot:2501215101.Ar-7213, lot: 12812.Ar-7200, lot: 12795.However it could not be confirmed which device has led to the reported issue and if the devices are available for evaluation.

• Brand Name: #5 FIBERWIRE W/ NEEDLES FOR SUTUREPLATE
• Common Device Name: SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10746476
• Report Number: 1220246-2020-02270
• Device Sequence Number: 14246575
• Product Code: GAT
• UDI-Device Identifier: 00888867041431
• UDI-Public: 00888867041431
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K122374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 10/28/2020

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: #5 FIBERWIRE W/ NEEDLES FOR SUTUREPLATE
• Device Catalogue Number: AR-7213
• Device Lot Number: 12812
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2020
• Initial Report FDA Received Date: 10/28/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other