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 Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is unknown if there was patient involvement.No patient information was provided.It is unknown when device broke.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Facility and contact information is unknown.Reporter is a synthes sales consultant.The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history record review has been requested.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, the grasping end of a posterior lumbar interbody fusion (plif) holder had broken.It was unknown if there was patient or procedure involvement.This report is for a plif holder.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
A device history record (dhr) review could not be performed as the lot a7ta18 does not correspond to a tuttlingen device.Product was not returned.Based on the information available, it has been determined that no corrective and 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.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: 7881705
• Report Number: 2939274-2018-53804
• Device Sequence Number: 1939641
• Product Code: LXH
• UDI-Device Identifier: 10705034774541
• UDI-Public: (01)10705034774541
• Combination Product (Y/N): N
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2018

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: A7TA18
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/13/2018
• Supplement Date Received by Manufacturer: 10/02/2018
• Initial Report FDA Received Date: 09/17/2018
• Supplement Report FDA Received Date: 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1