MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 5MM FBALL,10F,CBD,S; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Catalog Number	S-5B-C-10F-G1
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The actual device was returned for evaluation.Quality engineering evaluated the device and it was determined that a piece of the cutter device was broken and stuck inside the attachment device.Therefore, the reported condition was confirmed.The piece of the cutter was examined using 25x magnification and rechecked on an optical comparator.It was noted that a full assessment of the device could not be performed due to the condition the device was received in.The cause for the cutter getting being stuck within the attachment device was likely due to debris and worn ball bearings which prevented the lock tabs from moving into place.The assignable root cause was traced to improper cleaning/handling of the attachment device which is user error.Concomitant medical products: attachment device.(b)(4).
Event or Problem Description
It was reported that during receipt of the attachment device, it was observed that the cutter device was stuck in the attachment device.During in-house engineering evaluation, it was determined that a piece of the cutter device was broken off below the laser marking and was stuck in the attachment device.It was noted that only a piece of the utter was received.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in the surgical procedure, or if a spare device was available for use.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.The date of event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: 5MM FBALL,10F,CBD,S
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10694601
• Report Number: 1045834-2020-01718
• Device Sequence Number: 3124284
• Product Code: HBC
• UDI-Device Identifier: 00845384015352
• UDI-Public: 0845384015352
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K113476
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/01/2020

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 Expiration Date: 12/28/2024
• Device Catalogue Number: S-5B-C-10F-G1
• Device Lot Number: N473140618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/05/2020
• Initial Report FDA Received Date: 10/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1