MAUDE Adverse Event Report: DEPUY SPINE INC SPOT 2MM, 45 UP ANGLE MICROPI; RONGEUR

Model Number	292904202
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
The item #279702040 got bent and twisted during hole creation in hard bone.The tip of item 292904202 broke while the surgeon was trying to remove tissue.The broken piece was retrieved and discarded.Was surgery delayed due to the reported event? no.Was procedure successfully completed? yes.Were fragments generated? yes.If yes, were they removed easily without additional intervention? yes.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.This complaint involves two (2) device.
Additional Manufacturer Narrative
Product complaint # (b)(4).Udi: (b)(4).Report type: correction.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.During visual inspection, it was observed that the distal end of the device was broken.The broken off piece was not returned for evaluation.Device failure/ defect identified? yes.A manufacturing record evaluation could not be performed as no manufacturing records could be found for this part # 292904202 / lot # kw1340483 combination.A definitive assignable root cause for the post manufacturing damage could not be determined based on the provided information.This complaint is confirmed however no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.No new, unique or different patient harms were identified because of this evaluation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).

• Brand Name: SPOT 2MM, 45 UP ANGLE MICROPI
• Common Device Name: RONGEUR
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8898517
• Report Number: 1526439-2019-51980
• Device Sequence Number: 329304
• Product Code: HTX
• UDI-Device Identifier: 10705034225685
• UDI-Public: (01)10705034225685
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/30/2019

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 Model Number: 292904202
• Device Catalogue Number: 292904202
• Device Lot Number: KW1340483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2019
• Initial Date Received by Manufacturer: 07/30/2019
• Supplement Date Received by Manufacturer: 08/28/2019; 10/16/2019
• Initial Report FDA Received Date: 08/15/2019
• Supplement Report FDA Received Date: 09/23/2019; 10/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1