MAUDE Adverse Event Report: DEPUY SPINE INC ALIF DISC RONGEUR STRAIGHT 3MM

Model Number	273505103
Date of Event	10/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: visual inspection: alif disc rongeur straight 3mm (part: 273505103, lot: km841147, lot: 1) was returned and received at us cq.Upon visual inspection at cq, it is observed that the bottom slider was broken at the distal end.One of the he spring components between the jaws of the device got deformed which would impact functionality of the device.Device failure/ defect identified? yes.Dimensional inspection: dimensional inspection of the received device could not be performed at cq due to the device design and post manufacturing damage.Document/ specification review: the following drawings were reviewed during the investigation: -disc rongeur, straight: no design issues or discrepancies were noted during the investigation.Complaint confirmed? yes.Investigation conclusion: the complaint is being confirmed for alif disc rongeur straight 3mm (part: 273505103, lot: km841147) as the bottom slider was broken at the distal end and one of the he spring components between the jaws of the device got deformed.While a definitive root cause could not be identified, it is possible that the components of the device might have encountered unintended forces.No product design or manufacturing issues were identified, and no new malfunctions were identified either.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.,during the disc preparation for an l5/s1 l4/5 alif (anterior lumbar interbody fusion) the surgeon was using the 3mm straight disc ronguer on tough disc material and bent the tips of the instrument.They do not close and need to be replaced from this set.I have taken a photo and tagged the instrument.This complaint involves one (1) device.Customer quality investigation: the instrument(s) was not returned, and the investigation will be completed based on the supplied image(s) located in notes & attachments section of the product complaint.The image(s) was reviewed, and the complaint condition of bent could not be confirmed as the image didn¿t show the distal tip to show if there are any issues.As the instrument(s) was not returned and as received, dimensional, material or drawing reviews are not applicable.A manufacturing record evaluation was not performed as the lot number could not be determined from the image(s).There is no indication that a design or manufacturing issue contributed to the complaint as the circumstances during the time of the event are unknown.No new malfunctions were observed during this investigation that may have contributed to the complaint condition.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.Device history lot: a review of the receiving inspection (ri) for 3mm straight disc rongeur was conducted identifying that lot number km841147 was released in a single batch.Batch1: lot was released on feb 17, 2017 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer., a review of the receiving inspection (ri) for 3mm straight disc rongeur was conducted identifying that lot number km841147 was released in a single batch.Batch1: lot was released on feb 17, 2017 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Device history review: the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.,the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020 during the disc preparation for an l5/s1 l4/5 alif (anterior lumbar interbody fusion), the surgeon was using the alif disc rongeur straight 3mm on tough disc material and bent the tips of the instrument.The were unable to close.There was no surgical delay.The procedure was successfully completed.There was no patient consequence.This report is for one (1) alif disc rongeur straight 3mm.This is report 1 of 1 for (b)(4).

• Brand Name: ALIF DISC RONGEUR STRAIGHT 3MM
• Common Device Name: RONGEUR
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11117284
• Report Number: 1526439-2021-00009
• Device Sequence Number: 3698426
• Product Code: HTX
• UDI-Device Identifier: 10705034190136
• UDI-Public: (01)10705034190136
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/09/2020

1 Device 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: 273505103
• Device Catalogue Number: 273505103
• Device Lot Number: KM841147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 01/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No