MAUDE Adverse Event Report: DEPUY SPINE INC VIPER PRIME COMP DRIVER, X25; INSTRUMENT COMPRESSION

Model Number	286750083
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product investigation was conducted.Visual inspection: the viper prime comp driver, x25 (part # 286750083 lot # km866436) was received at us cq.The visual inspection of the received device indicated that the distal tip was stripped and deformed in counter clockwise direction.There were no other defects identified.The received condition of the device is consistent with the complaint condition thus the complaint is confirmed.Dimensional inspection: dimensional inspection was not performed due to post-manufacturing damage.Conclusion: the complaint was confirmed for the received viper prime comp driver, x25 (part # 286750083, lot # km866436) as the distal tip was stripped.Although no definitive root-cause can be determined, it is possible that the device experienced unintended forces such as over-torque during use.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.A device history record (dhr) review was conducted: a review of the receiving inspection (ri) for viper prime comp driver, x25 was conducted identifying that lot number km866436 was released in a single batch.Batch1: lot qty of (b)(4) units were released on 11oct2018 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.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 in 2020, during the insertion of the innies, during final tightening the screwdrivers would not insert properly.It was very difficult to make the torque limiting.During the same procedure, the compression screwdriver was also damaged during the compression.The procedure was completed successfully with ten (10) minutes delay.There were no patient consequences.During manufacturer's investigation of the returned devices it was identified that the distal tip of the viper prime comp driver was stripped and deformed in counter clockwise direction.This device condition was reassessed and determined to be reportable on (b)(6) 2020.This report is for one (1) viper prime comp driver, x25.This is report 2 of 2 for (b)(4).

• Brand Name: VIPER PRIME COMP DRIVER, X25
• Common Device Name: INSTRUMENT COMPRESSION
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10225481
• Report Number: 1526439-2020-01299
• Device Sequence Number: 14010216
• Product Code: HWN
• UDI-Device Identifier: 10705034507736
• UDI-Public: (01)10705034507736
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: EXEMPT
• 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
• Report Date (Section B): 04/28/2020

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: 286750083
• Device Catalogue Number: 286750083
• Device Lot Number: KM866436
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/25/2020
• Initial Report FDA Received Date: 07/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR