MAUDE Adverse Event Report: DEPUY SPINE INC SPOT 11F SUCTION TUBE; CATHETER AND TIP, SUCTION

Catalog Number	292908011
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A portion of the distal tip was broken but was not returned with the device.Additionally, a portion of the distal end is discolored/faded.No other issues were identified during inspection.A manufacturing related potential cause was not suspected, therefore, no manufacturing record evaluation is required.The complaint condition is confirmed.While no definitive root cause could be determined it is possible that the device encountered unintended forces (during usage or handling at the time of surgery).During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.
Event or Problem Description
The tip of the viper final tightener driver #286745550 got stripped during the final tightening process.The tip of the suction #292908011 is damaged.It seems that it got worn out due to repeated use along side cutting instruments.No-charge replacements needed for both.Po#2697726.Customer reference/po/service: (b)(4), was surgery delayed due to the reported event?: unknown, was procedure successfully completed?: unknown, were fragments generated?: unknown, if yes, were they removed easily without additional intervention?: unknown, patient status/ outcome / consequences: no, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown, is the patient part of a clinical study --> unknown, (b)(4).Device property of: none, device in possession of: none, (b)(4).Device property of: none, device in possession of: none.By checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst.True.This complaint involves two (2) devices.

• Brand Name: SPOT 11F SUCTION TUBE
• Common Device Name: CATHETER AND TIP, SUCTION
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9564915
• Report Number: 1526439-2020-00277
• Device Sequence Number: 2490179
• Product Code: JOL
• UDI-Device Identifier: 10705034225906
• UDI-Public: 10705034225906
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 292908011
• Device Lot Number: ER113216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/23/2019
• Initial Report FDA Received Date: 01/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1