MAUDE Adverse Event Report: DEPUY SPINE INC 5.5 EXP VERSE SCREW 7.0 X 40; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	199721740
Medical Device Problem Codes	Break (1069); Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: additional procode: kwp, kwq, mnh, mni, osh.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 or Problem Description
It was reported that on (b)(6) 2020, the threads on an 7.0x40mm expedium verse screw at left l5 came dislodged and prevented the verse correction key from threading down entirely making it impossible to final tighten the setscrew.The screw was removed and replaced with another 7.0x40mm expedium verse screw.The procedure was successfully completed with a surgical delay of ten (10) minutes.The patient status/outcome is unknown.Concomitant device reported: unknown tightener (part# unknown, lot# unknown, quantity unknown ).Unknown locking/set screws (part# unknown, lot# unknown, quantity unknown ).This report is for one (1) 5.5 exp verse screw 7.0 x 40.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.H3, h6: investigation summary investigation flow: device interaction/functional visual inspection: the 5.5 exp verse screw 7.0 x 40 (part #: 199721740, lot #: 258745 ) was received at us cq.Visual inspection of the complaint device showed the expedium verse screw head (part # 887042533) had scratches and a worn out thread.The internal hexalobe of the poly screw shank (part #: 887046463) was present but dented and worn out as well.There was a deep scratch on the screw head similar to a ring mark.No physical damage or defect was reported on the double helical external thread of the screw.The cap (part # 887042534) could be seen but no damage could be reported.The ring was not visible.The screw could pivot freely without any resistance.Functional test: a functional assessment was not performed with the complaint device due to the post manufacturing damage of the device assembly.However due to the deep scratch on the screw head, and the screw pivoting freely without resistance, it is possible that the ring was broken and fall off.Can the complaint be replicated with the returned device? yes, there could be a defect due to the way the screw was pivoting that could contribute to the complaint condition.Dimensional inspection: no dimensional inspection was performed due to post-manufacturing condition of the returned device and due to requiring destruction of the device to accurately dimensionally inspect.Document/specification review: no design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed for the 5.5 exp verse screw 7.0 x 40 (part #: 199721740, lot #: 258745 ) as there were physical damage to the returned device assembly.Per the investigation it is likely that the ring was broken and fall off during usage of the device.Additionally, the hexalobe of the screw shank was dented and rounded on the edges.This could be due excessive forces applied to tighten the screw.No root cause could definitely be determined for the reported complaint condition but it is likely excessive force application could have contributed to the device failure and making it difficult to final tighten the screw set.No new, unique or different patient harms were identified as a result of this evaluation.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 history lot: the dhr of product code 199721740, lot 258745, was reviewed and no non-conformance was observed during the manufacturing process.The product was released on october 21, 2019.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.

• Brand Name: 5.5 EXP VERSE SCREW 7.0 X 40
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10421091
• Report Number: 1526439-2020-01489
• Device Sequence Number: 2795161
• Product Code: NKB
• UDI-Device Identifier: 10705034442112
• UDI-Public: (01)10705034442112
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K142185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2020

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: 199721740
• Device Catalogue Number: 199721740
• Device Lot Number: 258745
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2020
• Initial Date Received by Manufacturer: 07/24/2020
• Supplement Date Received by Manufacturer: 09/21/2020
• Initial Report FDA Received Date: 08/18/2020
• Supplement Report FDA Received Date: 09/22/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN LOCKING/SET SCREWS; UNKNOWN TIGHTENER