MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MIS TI CFX FEN POLY 6X50; BONE CEMENT, POSTERIOR SCREW AUGMENTATION

Model Number	186727650
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The implant(s) was not returned and instead the investigation will be done based on the received image(s).The image(s) was reviewed, and the complaint condition could not be confirmed as the stripped threads are unable to be seen from the image.As the implant(s) was not returned, an as received condition, dimensional inspection, material or drawing reviews are not applicable.A definitive assignable root cause could not be determined based on the provided information.During the investigation, no product design 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 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 (b)(6) reports an event as follows: it was reported that during a procedure on (b)(6) 2020, it was discovered that the thread of the screw was defective.The screw was inserted and in situ, when trying to tighten the innie, it was found that the thread was defective.The screw was taken out and replaced with another one.No significant surgical delay nor patient harm reported.This report is for a viper cortical fix fenestrated screw.This is report 1 of 1 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H4: the dhr of product code 186727650, lot 277561, was reviewed and no non-conformance was observed during the manufacturing process.The product was released on march 27, 2020.Qty.(b)(4).The dhr was electronically reviewed.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 completed: upon visual inspection, scratches and nicks were observed around the hexalob feature of the screw shank.No other visual deformity was observed.The relevant drawings were reviewed; no design issues or discrepancies were identified.A dimensional inspection was not performed as relevant dimensions of internal components could not be achieved without device destruction.The overall complaint was not confirmed as there was not physical damage observed that could prevent the device from performing as intended.Only scratches (cosmetic defects) were observed and those occurred because the device was used.No definitive root cause could be determined based on the provided information.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: MIS TI CFX FEN POLY 6X50
• Common Device Name: BONE CEMENT, POSTERIOR SCREW AUGMENTATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10490349
• Report Number: 1526439-2020-01606
• Device Sequence Number: 19474763
• Product Code: PML
• UDI-Device Identifier: 10705034282572
• UDI-Public: (01)10705034282572
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K160879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/10/2020

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
• Operator of Device: Health Professional
• Device Model Number: 186727650
• Device Catalogue Number: 186727650
• Device Lot Number: 277561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Initial Date Received by Manufacturer: 08/10/2020
• Supplement Date Received by Manufacturer: 09/10/2020; 09/29/2020
• Initial Report FDA Received Date: 09/03/2020
• Supplement Report FDA Received Date: 09/10/2020; 10/09/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN LOCKING/SET SCREWS; UNKNOWN RODS; UNKNOWN TIGHTENER