MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE FEN SCR 6.0X40; BONE CEMENT, POSTERIOR SCREW AUGMENTATION

Model Number	199723640
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional procode: mni.A manufacturing record evaluation could not be performed as the lot number could not be determined from the image received.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.(b)(4).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 patient underwent revision surgery on an unknown date.During the surgery, a broken screw was removed, along with another screw, both rods, and both set screws.The broken screw was discovered on preoperative imaging.This report is for a 5.5 expedium verse 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.Visual inspection: the 5.5 exp verse fen scr 6.0x40 (part # 199723640 & lot # 213706) was received at us cq.The screw component of the assembly (part # 887046744) was broken below the screw head.The whole broken screw component was received.The received condition is consistent with the complaint condition thus the complaint is confirmed.Device failure/defect identified? yes; screw component was broken.Dimensional inspection: major thread diameter of the assembly was measured.Specified dimensions: major thread diameter = 6.00mm +/- 0.1mm.Measured dimensions: major thread diameter = 5.92mm; conforming.Document/specification review: drawing(s) reviewed: (current & manufactured revisions) no issues.Conclusion: the complaint was confirmed for the 5.5 exp verse fen scr 6.0x40 (part # 199723640 & lot # 213706).The screw component of the assembly was broken.Although no definitive root cause could be determined, it is possible that the device encountered unintended forces which lead to the rupture of the screw stem, and the breakage of the screw head tabs.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 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: the dhr of product code: 199723640, lot : 213706.Was electronically reviewed and no non-conformances were observed during the manufacturing process.The product was released on: 25.08.2018, qty: (b)(4).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
Revision surgery was performed on (b)(6) 2020.
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.Customer quality investigation: the complaint device was not received for investigation.The following investigation is based on the image(s).The image(s) was reviewed, and the complaint condition could be confirmed as x-ray displays that the screw is broken in two pieces.No other issue(s) was identified with the device.Since the device was not returned, a dimensional inspection and a functional test were not able to be performed.A manufacturing record evaluation could not be performed as the lot number could not be determined from the image provided.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.

• Brand Name: 5.5 EXP VERSE FEN SCR 6.0X40
• 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: 10448684
• Report Number: 1526439-2020-01524
• Device Sequence Number: 17033697
• Product Code: PML
• UDI-Device Identifier: 10705034403090
• UDI-Public: (01)10705034403090
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K160879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/30/2020

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: 199723640
• Device Catalogue Number: 199723640
• Device Lot Number: 213706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2020
• Initial Date Received by Manufacturer: 07/30/2020
• Supplement Date Received by Manufacturer: 09/02/2020; 09/23/2020; 10/15/2020
• Initial Report FDA Received Date: 08/25/2020
• Supplement Report FDA Received Date: 09/22/2020; 10/07/2020; 10/16/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5.5 EXP VERSE FEN SCR 6.0X45; 5.5 EXP VERSE UNITIZED SET SCR; MMSI ROD PREBENT, 5.5 X40MM, T; 5.5 EXP VERSE FEN SCR 6.0X45; 5.5 EXP VERSE UNITIZED SET SCR; MMSI ROD PREBENT, 5.5 X40MM, T
• Outcome Attributed to Adverse Event: Required Intervention