MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC VERTEBRAL BODY SPREADER-; FORCEPS

Model Number PDL114

Device Problems Mechanical Problem (1384); Device Slipped (1584)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/05/2020

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 disc rongeur straight without teeth screw came out causing the instrument to not bite down and release; the vertebral body spreader screw came out during surgery.Another set was used to continue.There was no surgical delay.There was no patient harm.This report is for a vertebral body spreader.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.H3,h4,h6- product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device history lot part number: pdl114, lot number: a7oa40 (wo # 901764), synthes lot number: 5102284, manufacturing site: tuttlingen, release to warehouse date: 13-oct-2005.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.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.

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.H3, h6: a product investigation was completed: visual inspection of the complaint device showed the pin was missing.The device appeared used with cosmetic issues such as scratches, but they did not affect the functionality of the device.A functional assessment was not able to be performed due the post manufacturing damage of the device.Without the pin holding the ratchet in place the device could not perform as intended.No dimensional inspection was performed due to requiring destruction of the device, and device assembly and geometry limits ability to accurately dimensionally inspect.The current and manufactured to drawings were reviewed; no design issues or discrepancies were identified.This complaint is confirmed as the visual inspection of the complaint device showed that the pin was missing.Although no definitive root-cause can be determined it is likely that a component failure occurred during use.No new, unique or different patient harms were identified as a result of this evaluation.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 on the investigation findings, it has been determined that no corrective and/or preventive 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.

• Brand Name: VERTEBRAL BODY SPREADER-
• Type of Device: FORCEPS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10102211
• MDR Text Key: 192769379
• Report Number: 2939274-2020-02565
• Device Sequence Number: 1
• Product Code: HTD
• UDI-Device Identifier: 10705034700212
• UDI-Public: (01)10705034700212
• 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,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 05/13/2020

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
• Device Operator: Health Professional
• Device Model Number: PDL114
• Device Catalogue Number: PDL114
• Device Lot Number: A70A40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Initial Date Manufacturer Received: 05/13/2020
• Initial Date FDA Received: 05/29/2020
• Supplement Dates Manufacturer Received: 06/10/2020; 03/03/2021
• Supplement Dates FDA Received: 06/12/2020; 03/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DISC RONGEUR STRAIGHT WO TEETH; DISC RONGEUR STRAIGHT WO TEETH