MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 9.2MM FACN,SHD; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Model Number	SHD-9AC-G1
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.Concomitant med products and therapy dates: burr device, (b)(6) 2020.Device history review: the actual device was not returned for evaluation; therefore, the reported condition was not confirmed.However, a device history review was performed which indicated that there were no non-conformances or abnormalities identified during the manufacture of the device that may have contributed to the reported condition.It was determined that the device passed all manufacturing and test requirements at the time of manufacture.Complaint history review: a complaint history review was performed which indicated that there were no complaints found for the reported lot number.A manufacturing record evaluation (mre) was performed for the finished device lot number, and there were no non-conformances identified that was related to the reported complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).
Event or Problem Description
This is report 1 of 2 of the same event: it was reported from (b)(6) that before surgery while prepping, it was discovered that two burr devices broke at the proximal end (the end that inserted into the handpiece device).The reporter stated that both devices were from the same lot number.The reporter further stated that all the devices were discarded.It was reported that there was a five-minute delay to the surgical procedure and spare devices were available for use.It was further reported that the procedure was completed as intended.There was no patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown.However, it was reported that the event occurred in 2020.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: 9.2MM FACN,SHD
• 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: 10536669
• Report Number: 1045834-2020-01468
• Device Sequence Number: 11766326
• Product Code: HBE
• UDI-Device Identifier: 00845384012917
• UDI-Public: 00845384012917
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K113476
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/02/2020

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: SHD-9AC-G1
• Device Catalogue Number: SHD-9AC-G1
• Device Lot Number: N123136406
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/02/2020
• Initial Report FDA Received Date: 09/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1