MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH ANTI BACKOUT SCREW, 20 MM; APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY

Model Number	172803020
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been 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 or Problem Description
It was reported that on (b)(6) 2020, during l3-s1 alif surgery, upon instrumenting the l4/l5 level and after inserting mtf alif allograft into the disc space, the surgeon requested to use the depuy bowti anterior buttress staple.He positioned the bowti and then used the awl to perforate the cortex and prepare a hole for the screw.When inserting the screw, he noticed that the purchase wasn't strong and that the screw seemed to fall into the hole rather than thread in.He then removed the bowti staple and screw and moved the implant over so that he could create a new hole for the screw.Again, he experienced the same problem.Again, he removed the implant and chose not to re-instrument with the bowti.There was a surgical delay of fifteen (15) minutes.Patient status is unknown.The procedure was successfully completed.Concomitant device reported: anti backout screw, 25mm (part #: 172803025, lot #: wa24956, quantity 1); staple, 24mm (part #: 172802024, lot #: wa21807, quantity 2); screws (part#: unknown, lot#: unknown, quantity unknown).This report is for one (1) anti backout screw, 20mm.This is report 2 of 4 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.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.
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.H3, h6: a product investigation was conducted.Visual inspection: the anti backout screw, 20 mm (p/n: 172803020, lot #: wa24073) was returned and received assembled with the staple, 24 mm (p/n: 172802024, lot #: wa21807) at us cq.Upon visual inspection, no issues were identified with the returned device.Functional test: the functional test was not performed as the awl used to perforate the cortex and prepare the hole for the screw was not returned.Dimensional inspection: the dimensional inspection was performed on the returned device.The outer diameter of the screw threads was measured to and is within the specification per relevant drawings.Document/specification review: based on the date of manufacture the relevant drawings, reflecting the current and manufactured revision were reviewed investigation conclusion: the complaint condition was unconfirmed for the anti backout screw, 20 mm (p/n: 172803020, lot #: wa24073).There is no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that 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.H3, h4, h6: a device history record (dhr) review was conducted: a review of the receiving inspection (ri) for anti-blackout screw, 20mm was conducted identifying that lot number wa24073 was released in a single batch.Batch1: lot qty of 103 units were released on 14 oct 2019 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: ANTI BACKOUT SCREW, 20 MM
• Common Device Name: APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9812932
• Report Number: 1526439-2020-00681
• Device Sequence Number: 19555799
• Product Code: KWQ
• UDI-Device Identifier: 10705034015668
• UDI-Public: (01)10705034015668
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K021039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 172803020
• Device Catalogue Number: 172803020
• Device Lot Number: WA24073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2020
• Initial Date Received by Manufacturer: 02/12/2020
• Supplement Date Received by Manufacturer: 03/19/2020; 04/01/2020
• Initial Report FDA Received Date: 03/10/2020
• Supplement Report FDA Received Date: 03/31/2020; 04/03/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ANTI BACKOUT SCREW, 25 MM; STAPLE, 24 MM (QTY2); UNKNOWN SCREWS
• Outcome Attributed to Adverse Event: Required Intervention