MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI MATRIXMIDFACE SCREW SELF-DRILLING 5MM; BONE PLATE

Model Number	04.503.225.01
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is unknown when device malfunctioned.Additional device product code: dzl.Device is not implanted/explanted.Without a lot number the device history records review could not be completed.The subject device has been received and the product evaluation is in progress.No conclusion can be drawn.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 the patient underwent cranioplasty on (b)(6) 2018.During the procedure there were two sets of titanium matrixmidface self drilling screws available in the procedure set that was prepared by the facility, each set has a quantity of 80 screws.One set was opened during the surgery.The surgeon attempted to use 20 screws from the set, but they were all noted to be dull and had difficulty putting the screws into the skull.The surgeon then switched to the matrix neuro set and was able to successfully complete the procedure with the 4mm screws without difficulty.There was a 20 minutes delay in surgery.There was no patient consequence.During manufacturer¿s preliminary analysis of the returned device it was observed that the screw is bent.This device condition was re-evaluated and determined to be reportable on (b)(6) 2018.This report is for one (1) ti matrixmidface screw self-drilling 5mm.This is report 1 of 1 for complaint (b)(4).
Event or Problem Description
Concomitant devices reported: ti matrixmidface screw self--drilling 4mm (product# 04.503.224.01, lot#lotunknown, quantity 122) , ti matrixmidface screw self--drilling 4mm (product# 04.503.224.01, lot# h370752, quantity 1) , ti matrixmidface screw self--drilling 4mm (product# 04.503.224.01, lot# h424278, quantity 3) , ti matrixmidface screw self--drilling 4mm (product# 04.503.224.01, lot# h435226, quantity 1) , ti matrixmidface screw self--drilling 4mm (product# 04.503.224.01, lot# h457167, quantity 6) , ti matrixmidface screw self--drilling 4mm (product# 04.503.224.01, lot# h481668, quantity 34) , ti matrixmidface screw self--drilling 4mm (product# 04.503.224.01, lot# h510475, quantity 14) , ti matrixmidface screw self--drilling 4mm (product# 04.503.224.01, lot# h624356, quantity 47).
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.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.
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.In addition to the reported dull screws one device of product code 04.503.225.01 was also received without a reported complaint condition.Upon a visual inspection, it was identified that the cruciform recess of the screw was severely damaged and unusable.As no issue was reported with this device, reported condition does not match the as received condition of a damaged drive recess.The complaint is not confirmed.Dimensional inspection: due to the damage to the screw recess, a dimensional inspection of the drive recess is not possible.Document/specification review: as the damage to the device is visually identifiable and the specific lot/manufacturing information is not available, a specification review will not be performed.The exact cause for the damage to the screw recess is not able to be determined.It is possible that the damage is due to either transport damage between the customer and customer quality.But the exact cause is not able to be determined.This complaint will be categorized as confirmed due to the damage that is observed on the device.During this investigation no product design or manufacturing issues 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.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: TI MATRIXMIDFACE SCREW SELF-DRILLING 5MM
• Common Device Name: BONE PLATE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7837286
• Report Number: 2939274-2018-53551
• Device Sequence Number: 19126496
• Product Code: JEY
• UDI-Device Identifier: 10887587019147
• UDI-Public: (01)10887587019147
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K083388
• 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,Followup
• Report Date (Section B): 07/03/2018

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: 04.503.225.01
• Device Catalogue Number: 04.503.225.01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2018
• Initial Date Received by Manufacturer: 08/20/2018
• Supplement Date Received by Manufacturer: 09/03/2018; 09/17/2018
• Initial Report FDA Received Date: 08/31/2018
• Supplement Report FDA Received Date: 09/04/2018; 09/18/2018
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: THERAPY DATE: UNKNOWN