MAUDE Adverse Event Report: DEPUY SPINE INC MIS ALIGNMENT DEVICE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	279726400
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is a j&j employee.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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020 during an unknown procedure, the tip of the misalignment device was malformed.The device missed its target hole in the implant and the clinician attempted to tighten it.After using an unknown needle to test if the tip of the misalignment device was clear, it was observed that the needle could not go through the tip and the tip was damaged.There was no surgical delay.There was no patient consequence.The procedure was completed with a similar product.This report is for one (1) mis alignment device.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.H10 additional narrative: h3, h4, h6: a review of the receiving inspection (ri) for mis alignment device was conducted identifying that lot number gm3748303 was released in a single batch.Batch1: lot qty of (b)(4) units were released on 01-apr-2013 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.Visual inspection: the mis alignment device (product code: 279726400, lot#: gm3748303, qty:(b)(4)) was received at us customer quality (cq).Upon visual inspection at cq, the distal tip of the device appeared to be deformed.No other discrepancies were identified during the visual inspection.Device failure/defect identified? yes.Dimensional inspection: dimensional inspection cannot be performed due to post manufacturing damage.Documentation/ specification review: the following drawing was reviewed: viper mis alignment device assembly: (current and manufactured) no design issues or discrepancies were found during this investigation.Complaint confirmed? yes investigation conclusion: visual inspection and document specification review of the received device was performed at cq.The complaint can be confirmed as the mis alignment device (product code: 279726400, lot#: gm3748303, qty:(b)(4)) has a deformed tip.The deformed tip condition could have caused the complaint condition.A definitive root cause could not be determined for the reported problem, but the tip could have been damaged due to the application unintended forces.During the investigation, no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.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.

• Brand Name: MIS ALIGNMENT DEVICE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10540412
• Report Number: 1526439-2020-01707
• Device Sequence Number: 14243518
• Product Code: LXH
• UDI-Device Identifier: 10705034199481
• UDI-Public: (01)10705034199481
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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,Followup
• Report Date (Section B): 08/21/2020

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: 279726400
• Device Catalogue Number: 279726400
• Device Lot Number: GM3748303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2020
• Initial Date Received by Manufacturer: 08/21/2020
• Supplement Date Received by Manufacturer: 10/09/2020
• Initial Report FDA Received Date: 09/16/2020
• Supplement Report FDA Received Date: 10/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN GUIDES/SLEEVES/AIMING; UNKNOWN GUIDES/SLEEVES/AIMING