MAUDE Adverse Event Report: ARTHROCARE CORP. INLINE REUSABLE DRILL SPEEDHIP; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	23-2009
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during a hip scope drill broke at the end when in guide drilling, length of delay unknown.There was back-up device available to complete the procedure, no patient injuries reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10: h3,h6: the device reported, used in treatment, was not returned for evaluation.The relationship between the product and reported incident cannot be established.A review of manufacturing records for the reported lot number 20816011 found no non-conformances or anomalies during manufacturing process related to the reported event.A complaint history review found related failures.Without the reported product a fully visual and functional evaluation cannot be performed and customer¿s complaint cannot be confirmed.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 applied.(2) excessive levering of the instrument.No containment or corrective actions are recommended at this time.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
The inline reusable drill speedhip device, used in treatment, was returned for evaluation.A relationship between the device and reported incident was established.A review of manufacturing records for the reported lot number 20816011 found no non-conformances or anomalies during manufacturing process related to the reported event.A complaint history review found related failures; this failure mode will be trended to assess for any necessary corrective actions.Visual evaluation shows the shaft is broken at the drill stop.The device is intended for single use and can not be tested.The complaint was verified.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive force.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: INLINE REUSABLE DRILL SPEEDHIP
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 9706152
• Report Number: 3006524618-2020-00051
• Device Sequence Number: 17012799
• Product Code: LXH
• UDI-Device Identifier: 00885556724576
• UDI-Public: 00885556724576
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• 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,Followup,Followup
• Report Date (Section B): 06/19/2020

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 Model Number: 23-2009
• Device Catalogue Number: 23-2009
• Device Lot Number: 20816011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2020
• Initial Date Received by Manufacturer: 01/20/2020
• Supplement Date Received by Manufacturer: 03/16/2020; 06/18/2020
• Initial Report FDA Received Date: 02/13/2020
• Supplement Report FDA Received Date: 03/17/2020; 06/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1