MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM TI ROD 80MM; APPLIANCE,FIXATION,SPINA INTERLAMINAL

Model Number	498.120
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional pro-codes: mni, mnh, nkg, nkb, kwq.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.A review of the device history record has been requested.The investigation could not be completed; 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
"libertas": it was reported on (b)(6) 2019, that ten (10) 3.5mm titanium rod broke during reverse logistics audit of returned device at millstone.There was no patient involvement and no additional information is available.This complaint involves ten (10) devices.This report is for one (1) 3.5mm ti rod 80mm.This report is 7 of 10 for (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h4, h6: device history record (dhr) review was conducted: part number: 498.120.Lot number: 6882251 part manufacture date: 4/3/2012.Manufacturing location: brandywine.Part expiration date: n/a.Nonconformance noted: n/a.Dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of 3.5mm ti rod 80mm product was processed through the normal manufacturing and inspection operations with no rework no nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.H6: 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.H11 corrected data: g5.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h11: corrected data: g5.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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: 3.5MM TI ROD 80MM
• Common Device Name: APPLIANCE,FIXATION,SPINA INTERLAMINAL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9639754
• Report Number: 2939274-2020-00489
• Device Sequence Number: 16874683
• Product Code: KWP
• UDI-Device Identifier: 10705034788951
• UDI-Public: (01)10705034788951
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K142838
• 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,Followup,Followup
• Report Date (Section B): 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 498.120
• Device Catalogue Number: 498.120
• Device Lot Number: 6882251
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/08/2020
• Supplement Date Received by Manufacturer: 02/05/2020; 03/06/2020; 03/06/2020
• Initial Report FDA Received Date: 01/28/2020
• Supplement Report FDA Received Date: 03/05/2020; 03/06/2020; 03/06/2020
• Patient Sequence Number: 1