MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC LOCKING RING EXTRACTOR FOR USS VARIABLE AXIS SCREWS; TRAY,SURGICAL INSTRUMENT

Model Number 388.357

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 10/08/2019

Event Type  Injury  

Manufacturer Narrative

The device was received, the investigation is in progress, 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 Description

It was reported that on (b)(6) 2019, during an hardware removal procedure, the hexagonal screwdriver shaft and the locking ring extractor for uss were broken.The procedure was completed successfully by using an unknown synthes and an unknown nuvasive instruments.Time in surgery was extended for two - three ( 2-3) hours as other instruments from another set were used to extract implants.Patient outcome was good.This is report 2 of 2 for (b)(4).(b)(4) was created to capture the intra-op event (broken hexagonal screwdriver shaft and locking ring) and was linked to (b)(4), that captures the post-op event (broken screw).

Event Description

It was reported that on (b)(6) 2019, during an unknown procedure, the hexagonal screwdriver shaft and the locking ring extractor for uss were broken.It is unknown if the procedure was completed successfully and how it was completed.Time in surgery was extended two to three hours as instruments from another set were used to extract implants.Patient and procedure outcome was unknown.

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.Patient code 3191 used to capture additional medical/surgical intervention required.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.Locking ring extractor for uss variable axis screws was received at us cq.Upon visual inspection at cq, it is observed that the tabs at one end of a component of the device was severely deformed.The rest of the device shows normal wear consistent with the device use which would not contribute to the complaint condition.But no broken features were observed with the device.The device was unable to assemble due to the deformed component.During functional testing, the deformed tabs of the component would not allow to assemble the device.A visual inspection, and document/specification review were performed as part of this investigation.The complaint cannot be confirmed as there were no broken features observed with the device.But it is observed that the tabs at one end of a component of the device was severely deformed and unable to assemble.While a definitive root cause could not be determined, it is possible that 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.Device history lot , product code: 388.357, lot number: 3319613, manufacturing site: hägendorf, release to warehouse date: 26.Jan.2010.A manufacturing record evaluation 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.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: LOCKING RING EXTRACTOR FOR USS VARIABLE AXIS SCREWS
• Type of Device: TRAY,SURGICAL INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9239239
• MDR Text Key: 163784892
• Report Number: 2939274-2019-61753
• Device Sequence Number: 1
• Product Code: FSM
• UDI-Device Identifier: 10705034772547
• UDI-Public: (01)10705034772547
• 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,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/08/2019

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
• Device Operator: Health Professional
• Device Model Number: 388.357
• Device Catalogue Number: 388.357
• Device Lot Number: 3319613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2019
• Initial Date Manufacturer Received: 10/08/2019
• Initial Date FDA Received: 10/25/2019
• Supplement Dates Manufacturer Received: 10/31/2019; 10/22/2019; 11/21/2019
• Supplement Dates FDA Received: 10/31/2019; 11/14/2019; 11/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1