MAUDE Adverse Event Report: DEPUY SPINE INC 5.5 EXP VERSE FEN SCR 7.0X50; SUTURE,NONABSORBLE,STEEL,MONO/ MULTIFILAMENT,STERILE

Model Number	199723750
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.(b)(4).Reporter is company representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; 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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the patient had a surgery and during the surgery when inserting the correction key and a unitized set screw in the extended tap of a 7x50 mm exp verse cfx screw, both innies broke.That means a ring/chip broke off.The problem occurred in the lower level of the taps.After that the fixation with the correction key and the unitized set screw was not possible anymore, and the surgeon had to change the screw.All generated fragments were removed without any additional intervention.The surgery was completed successfully with 30 minutes delay.There were no patient consequences.Concomitant device reported: unknown key inserter/tightener (part# unknown, lot# unknown, quantity 1).This complaint involves two (2) devices.This is report 1 of 2 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.H10 additional narrative: h3, h6: 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.
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.The device history record (dhr) of product code: (b)(4) , lot: 271764 was electronically reviewed and no non-conformances were observed during the manufacturing process.The product was released on:10.02.2020 visual inspection: the 5.5 exp verse fem scr 7.0x50 was returned and received at us customer quality (cq).Upon visual inspection, it was observed that proximal threads on the shaft were deformed.The reduction tabs were broken, however, this damage was due to the removal of expedium verse screw reduction tabs at the completion of the procedure using tab remover per expedium verse spinal system technique guide.There was a bloodstain and small amount of cement observed on the device but this has no impact on the device functionality or the complaint condition.No other issues were identified with the returned device.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Furthermore, the complaint relevant dimensions cannot be checked for dimensional accuracy, because of the design of the device.Document/specification review based on the date of manufacture, the current and manufactured revision of drawings were reviewed and no issues related to design and manufacturing were observed.- expedium verse spinal system technique guide investigation conclusion the complaint condition was confirmed for the 5.5 exp verse fem scr 7.0x50.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.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 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
This is report 1 of 7 for (b)(4).

• Brand Name: 5.5 EXP VERSE FEN SCR 7.0X50
• Common Device Name: SUTURE,NONABSORBLE,STEEL,MONO/ MULTIFILAMENT,STERILE
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10129963
• Report Number: 1526439-2020-01142
• Device Sequence Number: 11303714
• Product Code: PML
• UDI-Device Identifier: 10705034402901
• UDI-Public: 10705034402901
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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,Followup
• Report Date (Section B): 05/27/2020

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: 199723750
• Device Catalogue Number: 199723750
• Device Lot Number: 271764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2020
• Initial Date Received by Manufacturer: 05/27/2020
• Supplement Date Received by Manufacturer: 07/21/2020; 07/22/2020; 08/04/2020
• Initial Report FDA Received Date: 06/08/2020
• Supplement Report FDA Received Date: 07/21/2020; 07/29/2020; 08/07/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5.5 EXP VERSE UNITIZED SET SCR; 5.5 EXP VERSE UNITIZED SET SCR; 5.5 EXP VERSE UNITIZED SET SCR; UNKNOWN SCREWDRIVERS; VERSE CORRECTION KEY