MAUDE Adverse Event Report: DEPUY SPINE INC POST IBF UI H 10MM 8DEG 26/9; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	PUI81006
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).(b)(6).Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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.
Event or Problem Description
It was reported that on (b)(6) 2021, the patient underwent for a spinal fusion surgery.During the surgery, the surgeon was doing a tlif at l5-s1 with severe degenerative disease and previous decompression of l2-s1.Also used conduit t/plif interbody system for implant.Surgeon used paddle distractors.The cage looked different, maybe longer.After tamping, it was noticed that something looked wrong with image and cage.Attempted to remove the cage but only half of the cage came out because it had sheared in half.There was a surgical delay of forty-five (45) minutes.There were no patient consequences.The procedure was successfully completed.Concomitant device reported: t-handle inserter (part# pet30101a, lot# e20di0683, quantity 1) unknown mallet (part# unknown, lot# unknown, quantity unknown) unknown distractor (part# unknown, lot# unknown, quantity unknown).This complaint involves one (1) device.This report is for one (1) post ibf ui h 10mm 8deg 26/9.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: investigation summary: visual inspection: the post ibf ui h 10mm 8deg 26/9 (part# pui81006, lot# e20la1712 qty# 1) was returned and received at us cq.Upon visual inspection, it is observed that the device was broken into two pieces and the pieces were deformed.Both pieces were retrieved and returned.No other issues were noted with the device.Dimensional inspection: dimensional inspection of the relevant feature of the received device was not performed at cq due to post manufacturing damage.Document/specification review: no design issues or discrepancies were found during this investigation.Complaint confirmed? yes.Investigation conclusion: the complaint is being confirmed for the returned device as it was broken and deformed.A definitive root cause could not be determined for the reported issue with the available information.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based upon these results, 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.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.Corrected data: d9, h3, h6.

• Brand Name: POST IBF UI H 10MM 8DEG 26/9
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham PA 02767
• Manufacturer (Section G): BRIDGEWATER DISTRIBUTION; 50 scotland boulevard; bridgewater MA 02324
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 12760840
• Report Number: 3013730328-2021-00054
• Device Sequence Number: 4326763
• Product Code: MAX
• UDI-Device Identifier: 04260557779972
• UDI-Public: 04260557779972
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K172888
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2021

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: 12/31/2025
• Device Model Number: PUI81006
• Device Catalogue Number: PUI81006
• Device Lot Number: E20LA1712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/12/2021
• Supplement Date Received by Manufacturer: 12/09/2021
• Initial Report FDA Received Date: 11/07/2021
• Supplement Report FDA Received Date: 12/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN CONDUIT INSERTER; UNKNOWN DISTRACTOR; UNKNOWN IMPACTION INSTRUMENTS
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 94 KG