MAUDE Adverse Event Report: DEPUY SPINE INC OPEN ALIGNMENT SLEEVE; CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	279726509
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number, the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective, and/or preventative action is proposed.This complaint will be accounted for, and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Investigation summary: complaint summary: lingard cssd phoned me regarding not being able to clean the fenestrated instruments used for cementing.More specifically, the open alignment sleeve x 6 and open alignment devices x6.The instrument(s) was not returned and instead the investigation will be done based on the supplied image(s) from the attachments (4 image(s), 1 sheet and 3 photos from the attachment(s).The image(s) was reviewed and the complaint condition could be confirmed as the photos show a white substance on the devices.As the instrument(s) was not returned an as received condition, dimensional inspection, material or drawing reviews are not applicable.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.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, six (6) open alignment sleeves and four (4) open alignment devices were unable to be decontaminated due to blockages.There was no patient consequence.There is no further information available.Concomitant device reported: fen mini cleaning stylet (part# 279726511, lot# unknown, quantity 1); anti-torque wrench self retaining (part# 286745155, lot# unknown, quantity 2); fen cannula plunger (part# 279726402, lot# unknown, quantity 1); fen cleaning stylet (part# 279726403, lot# unknown, quantity 1).This report is for one (1) open alignment sleeve.This is report 2 of 10 for (b)(4).
Additional Manufacturer Narrative
Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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 open alignment sleeve( part number:279726509 lot number: gm3522101) was received and the complaint condition could be confirmed as a white substance was found on the device.The image(s) was also reviewed and the complaint condition could be confirmed as the photos also show a white substance on the devices.It is likely that improper sterilization and cleaning of the device led to this issue.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 lot: a review of the receiving inspection (ri) for fen open alignment sleeve was conducted identifying that lot number gm3522101 was released in a single batch.Batch1: lot qty of units were released on 05 jan 2012 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.,a review of the receiving inspection (ri) for fen open alignment sleeve was conducted identifying that lot number gm3522101 was released in a single batch.Batch1: lot qty of units were released on 05 jan 2012 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 history batch: null,null.Device history review: the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.,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.

• Brand Name: OPEN ALIGNMENT SLEEVE
• Common Device Name: CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10848347
• Report Number: 1526439-2020-02201
• Device Sequence Number: 19705500
• Product Code: GEA
• UDI-Device Identifier: 10705034301525
• UDI-Public: (01)10705034301525
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/19/2020

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: 279726509
• Device Catalogue Number: 279726509
• Device Lot Number: GM3522101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Initial Date Received by Manufacturer: 10/19/2020
• Supplement Date Received by Manufacturer: 01/14/2021; 01/12/2020; 02/01/2021
• Initial Report FDA Received Date: 11/16/2020
• Supplement Report FDA Received Date: 01/15/2021; 01/29/2021; 02/01/2021
• 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: FEN CANNULA PLUNGER.; FEN CLEANING STYLET.; FEN MINI CLEANING STYLET.; OPEN ALIGNMENT DEVICE.; OPEN ALIGNMENT DEVICE.; OPEN ALIGNMENT DEVICE.; OPEN ALIGNMENT DEVICE.; OPEN ALIGNMENT SLEEVE.; OPEN ALIGNMENT SLEEVE.; OPEN ALIGNMENT SLEEVE.; OPEN ALIGNMENT SLEEVE.; OPEN ALIGNMENT SLEEVE.; VIPER2 - SELF RETAINING WRENCH.; FEN CANNULA PLUNGER; FEN CLEANING STYLET; FEN MINI CLEANING STYLET; OPEN ALIGNMENT DEVICE; OPEN ALIGNMENT DEVICE; OPEN ALIGNMENT DEVICE; OPEN ALIGNMENT DEVICE; OPEN ALIGNMENT SLEEVE; OPEN ALIGNMENT SLEEVE; OPEN ALIGNMENT SLEEVE; OPEN ALIGNMENT SLEEVE; OPEN ALIGNMENT SLEEVE; VIPER2 - SELF RETAINING WRENCH