MAUDE Adverse Event Report: DEPUY SPINE INC IEXP ROD CUTTER; INSTRUMENT, CUTTING, ORTHOPEDIC

Model Number 279729930

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 07/21/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter is synthes sales representative: the iexp rod cutter was not returned, and the investigation will be completed based on the supplied image.The image showed the rod bender with a crack that extended along the entirety of one of its faces.Due to the crack propagating entirely, the device is in fact broken.The overall complaint was confirmed.As the device was not returned an as received, dimensional, and material review were not applicable.The overall complaint for the product was confirmed.No definitive root cause was able to be determined as the circumstances surrounding the event are unknown.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed (based on the images) 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 iexp rod cutter was conducted identifying that lot number km875012 was released in 3 batches.Batch1: lot were released on 30may2019 with no discrepancies.Batch2: lot were released on 15mar2019 with no discrepancies.Batch3: lot were released on 30may2019 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.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 Description

It was reported that on (b)(6) 2020, the expedium rod cutter broke in conjunction with a prototype material during benchtop cutting of new rod materials (mp35n).The rod cutter fractured above the 5.5mm diameter cutting hole.There is no patient involvement.Concomitant device reported: unknown rod (part# unknown, lot# unknown, quantity unknown).This report is for one (1) iexp rod cutter.This is report 1 of 1 for (b)(4).

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: h3, h4, h6- the iexp rod cutter was not returned, and the investigation will be completed based on the supplied image.The image showed the rod bender with a crack that extended along the entirety of one of its faces.Due to the crack propagating entirely, the device is in fact broken.The overall complaint was confirmed.As the device was not returned an as received, dimensional, and material review were not applicable.The overall complaint for the product was confirmed.No definitive root cause was able to be determined as the circumstances surrounding the event are unknown.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed (based on the images) 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 iexp rod cutter was conducted identifying that lot number km875012 was released in 3 batches.Batch1: lot were released on 30may2019 with no discrepancies.Batch2: lot units were released on 15mar2019 with no discrepancies.Batch3: lot were released on 30may2019 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.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.

• Brand Name: IEXP ROD CUTTER
• Type of Device: INSTRUMENT, CUTTING, ORTHOPEDIC
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10396233
• MDR Text Key: 202563486
• Report Number: 1526439-2020-01468
• Device Sequence Number: 1
• Product Code: HTZ
• UDI-Device Identifier: 10705034200125
• UDI-Public: (01)10705034200125
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 279729930
• Device Catalogue Number: 279729930
• Device Lot Number: KM875012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2020
• Date Manufacturer Received: 08/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN RODS; UNKNOWN RODS