MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI MATRIXMIDFACE SCREW SELF-DRILLING 6MM; BONE PLATE

Model Number	04.503.226.01
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
Additional device product code: dzl.Device broke intra-operatively and was not fully implanted or explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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, during an unknown procedure, when the surgeon screwed the self-drilling screw in the hole previously done by a drill bit, the screw head broke and the screw itself stayed in the bone.It was unknown if there was a surgical delay.Patient outcome was unknown.This report is for one (1) ti matrixmidface screw self-drilling 6mm.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
Investigation flow: broken.Visual inspection: visual inspection of the returned device performed at customer quality (cq) confirmed the condition of screw breakage, which agrees with the reported complaint condition.The screw broke at its transition from screw head to screw shaft.Only the screw head was returned for investigation.The threaded shaft portion was not returned.The material surface at the fracture site appears homogeneous with no voids or abnormalities when viewed under 10x magnification.Device history record (dhr) review: a review of the device history records was unable to be performed since the lot number is unknown.Document/specification review: tabulated design drawing current revision for the family of 1.55mm matrix midface self-drilling screws was reviewed during this investigation.No product design issues or discrepancies were observed during this investigation.Dimensional inspection: the screw head diameter measured ø2.65mm at cq which is within specification of ø2.65mm +/-0.1mm per tabulated design drawing current revision.The screw shaft diameter at location of breakage could not be accurately measured at cq because only the screw head was returned.Material analysis: the design specified the screw to be manufactured from implant grade titanium aluminum niobium (tialnbr) alloy material.A material certification from the time of manufacture could not be reviewed during this investigation because a review of the device history records was unable to be performed since the lot number is unknown.The material surface at the fracture site appears homogeneous with no voids or abnormalities when viewed under 10x magnification.Conclusion: a definitive root cause for the screw breaking during insertion could not be determined based on the provided information.This complaint is confirmed, however, no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.No new, unique, or different patient harms were identified as a result of this evaluation.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.
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.Visual inspection: visual inspection of the returned device performed at customer quality confirmed the condition of screw breakage, which agrees with the reported complaint condition.The screw broke at its transition from screw head to screw shaft.Only the screw head was returned for investigation.The threaded shaft portion was not returned.The material surface at the fracture site appears homogeneous with no voids or abnormalities when viewed under 10x magnification.Dhr review: a review of the device history records was unable to be performed since the lot number was unknown.Document/specification review: no product design issues or discrepancies were observed during this investigation.Dimensional inspection: the screw head diameter measured ø2.65mm at cq (calipers ca215p) which is within specification of ø2.65mm +/-0.1mm the screw shaft diameter at location of breakage could not be accurately measured because only the screw head was returned.Material analysis: the design specified the screw to be manufactured from implant grade titanium aluminum niobium (tialnbr) alloy material.A material certification from the time of manufacture could not be reviewed during this investigation because a review of the device history records was unable to be performed since the lot number was unknown.The material surface at the fracture site appears homogeneous with no voids or abnormalities when viewed under 10x magnification.Conclusion: a definitive root cause for the screw breaking during insertion could not be determined based on the provided information.This complaint is confirmed however no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.No new, unique or different patient harms were identified as a result of this evaluation.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 6MM
• 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: 8039827
• Report Number: 2939274-2018-54842
• Device Sequence Number: 11059739
• Product Code: JEY
• UDI-Device Identifier: 10887587019178
• UDI-Public: (01)10887587019178
• 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): 10/19/2018

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: 04.503.226.01
• Device Catalogue Number: 04.503.226.01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2018
• Initial Date Received by Manufacturer: 10/19/2018
• Supplement Date Received by Manufacturer: 11/19/2018; 12/11/2018
• Initial Report FDA Received Date: 11/05/2018
• Supplement Report FDA Received Date: 12/12/2018; 01/08/2019
• Patient Sequence Number: 1