MAUDE Adverse Event Report: DEPUY SPINE INC SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE PISTOL GRIP GUIDE; GUIDE, SURGICAL, INSTRUMENT

Model Number	286810100
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sky varbl pistol grip guide (p/n: 286810100, lot #: kw1446832) was returned and received at us cq.Upon visual inspection, scratches and slight discoloration were observed on the device, but have no impact on the device functionality.The pistol grip guide is used to lock the guide to the plate, thereby allowing it to be used as a plate holder by orienting the tip of the pistol grip drill guide within the screw bone by squeezing the trigger to engage the ratchet mechanism to obtain a desired angle.There were no signs of broken observed with the returned device, but the trigger of the device was observed to be jammed as the travel only limited to three slots of the ratchet prius acp component.The interaction between the spreading tip and the spreader component when the trigger is pulled could have caused the jammed condition of the device.Both spreading tip and spreader components were examined visually and no defects were identified.This resulted in the failure of device functionality as the desired angle cannot be obtained.Hence confirming the complaint.The complaint condition was confirmed for the sky varbl pistol grip guide (p/n: 286810100, lot #: kw1446832) as the returned device was functionally broken.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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 variable pistol grip guide was conducted identifying that lot number kw1446832 was released in a single batch.Batch1: lot units were released on 05 mar 2015 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.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
It was reported that on an unknown date, during routine incoming inspection of a loaner set, it was observed that the skyline anterior cervical plate system variable pistol grip guide was broken.There was no procedure or patient involvement.This report is for one (1) skyline anterior cervical plate system variable pistol grip guide.This is report 1 of 1 for (b)(4).

• Brand Name: SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE PISTOL GRIP GUIDE
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10741297
• Report Number: 1526439-2020-02037
• Device Sequence Number: 1086619
• Product Code: FZX
• UDI-Device Identifier: 10705034215273
• UDI-Public: (01)10705034215273
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/29/2020

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: 286810100
• Device Catalogue Number: 286810100
• Device Lot Number: KW1446832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 10/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1