MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PLIF HOLDER; MISC ORTHO SURGICAL INSTR

Model Number	389.102
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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) 2019, the 90 degree up biting laminectomy punch was found to be broken and posterior lumbar interbody fusion (plif) holder was found dup lot scrap during reverse logistics audit of returned device at millstone.There was no patient involvement and no additional information is available.This complaint involves one (1) plif holder.This is 1 of 1 for report (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.The plif holder (part # 389.102/ lot # a7ka04) was received at us cq.The device was missing its pivot screw proximal to the handle.There were no other defects to note with the device.There was no evidence of device breakage.The overall complaint was not confirmed as the device was not broken.Dimensional inspection was not performed due to a conclusive finding of a missing component.The overall complaint was not confirmed for the received plif holder (part # 389.102/ lot # a7ka04) as there was no evidence of device breakage.The device was missing one of its pivot screws.Although no definitive root cause can be determined, the device may have lost one if its pivot screws while in use or while being handled.The pivot screw's stakes may have failed which lead to it being loose and coming undone.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.Part number: 389.102.Synthes lot # 4229416.Supplier lot # a7ka04.Release to warehouse date: (b)(6) 2001.Supplier: diwymed.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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: PLIF HOLDER
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9268159
• Report Number: 2939274-2019-61903
• Device Sequence Number: 2272450
• Product Code: LXH
• UDI-Device Identifier: 10705034774541
• UDI-Public: (01)10705034774541
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2019

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: 389.102
• Device Catalogue Number: 389.102
• Device Lot Number: 4229416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2019
• Initial Date Received by Manufacturer: 10/16/2019
• Supplement Date Received by Manufacturer: 12/04/2019
• Initial Report FDA Received Date: 11/01/2019
• Supplement Report FDA Received Date: 12/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1