MAUDE Adverse Event Report: ARTHROCARE CORP. EXTRACTION DEVICE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	OM-9630
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/16/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a shoulder scope surgery, the surgeon was removing an old anchor with a screwdriver.The end of the screwdriver broke off in the old anchor.It is unknown if there was a delay in the case or if a backup device was available to complete the procedure.No more information was available on medwatch form.
Additional Manufacturer Narrative
The reported extraction device intended for use in treatment, was not returned for evaluation.A relationship between the product and reported incident cannot be established as the product was not returned.Without the reported product a visual and functional evaluation cannot be performed and customer¿s complaint cannot be confirmed.From the information provided, ¿during a shoulder scope surgery, the surgeon was removing an old anchor with a screwdriver.The end of the screwdriver broke off in the old anchor.¿ an exact root cause cannot be determined without evaluation of the device; however, factors unrelated to the manufacture or design of the device that could have contributed to the reported event include: (1) excessive force.The instruction for use was reviewed and found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.The instruction for use states: as with any surgical instrument, careful attention should be made to assure that excessive force is not placed on this instrument.Excessive force can result in failure.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.
Additional Manufacturer Narrative
User facility importer report number added.

• Brand Name: EXTRACTION DEVICE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 8683536
• Report Number: 3006524618-2019-00281
• Device Sequence Number: 2207230
• Product Code: LXH
• UDI-Device Identifier: 00817470002928
• UDI-Public: 00817470002928
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: OM-9630
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/20/2019
• Supplement Date Received by Manufacturer: 06/13/2019; 07/30/2019
• Initial Report FDA Received Date: 06/10/2019
• Supplement Report FDA Received Date: 06/13/2019; 07/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: MW5086649
• Patient Sequence Number: 1