MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.0MM TI VAL CONDYLAR PLATE 2 HOLES HEAD-6 HOLES SHAFT; PLATE, FIXATION, BONE

Model Number	04.130.355
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is a synthes employee.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 that four (4) 1.5mm screws broke during the insertion into multiple variable angle (va) hand plates.After each attempt into new plates, the plates were repositioned to avoid the broken screws in the patient.The surgeon was advised to only finger tighten while inserting, however the screws kept breaking.There was a 45 minute surgical delay.The screw heads snapped off and the broken screws were left in the patient's bone.The procedure was completed successfully and the patient outcome is unknown.Concomitant devices: 1.5mm ti val y-plate 3 holes hd-7 holes shaft (product # 04.130.253, lot # 70p8809, quantity 1); 1.5mm ti val strut plate 8 holes-oblique-left (product # 04.130.259, lot # unknown, quantity 1); 1.5mm ti cortex scr slf-tpng with t4 stardrive recess 11mm (product # 04.214.111, lot # unknown, quantity 1); 1.5mm ti cortex scr slf-tpng with t4 stardrive recess 12mm (product # 04.214.112, lot # unknown, quantity 1); 1.5mm ti cortex scr slf-tpng with t4 stardrive recess 15mm (product # 04.214.115, lot # unknown, quantity 1); 2.0mm ti val straight plate 6 holes (product # 04.130.350, lot # 70p9866, quantity 1); 1.5mm ti cortex scr slf-tpng with t4 stardrive recess 12mm (product # 04.214.112, lot # unknown, quantity 1).This report is for one (1) 2.0mm ti val condylar plate 2 holes head-6 holes shaft.This is report 3 of 3 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.H3, h4, h6: part number: 04.130.355.Lot # as 58p8464.Manufacturing site: mezzovico.Release to warehouse date: 10 june 2020.A manufacturing record evaluation was performed for the not sterile lot number, and no non-conformances were identified.Visual inspection: the 2.0mm ti val condylar plate 2 holes head-6 holes shaft(p/n: 04.130.355, lot number: 58p8464) was received at us customer quality (cq).Upon visual inspection, the plate was noticed broken and the broken pieces were not returned.Device failure/defect identified? yes.Dimensional inspection: no dimensional inspection was performed due to post-manufacturing damage.Document/specification review: no design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as the plate was broken and the defect was identified on the device.No definitive root cause could be determined based on the provided information.No new, unique or different patient harms were identified as a result of this evaluation.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 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: 2.0MM TI VAL CONDYLAR PLATE 2 HOLES HEAD-6 HOLES SHAFT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11266286
• Report Number: 2939274-2021-00620
• Device Sequence Number: 3302622
• Product Code: HRS
• UDI-Device Identifier: 10886982113528
• UDI-Public: 10886982113528
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150099
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2021

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: 04.130.355
• Device Catalogue Number: 04.130.355
• Device Lot Number: 58P8464.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Initial Date Received by Manufacturer: 02/01/2021
• Supplement Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 02/02/2021
• Supplement Report FDA Received Date: 02/05/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1.5MM TI CRTX SCR SLF-TPNG W T4 STRDRIVE RCSS 11MM; 1.5MM TI CRTX SCR SLF-TPNG W T4 STRDRIVE RCSS 12MM; 1.5MM TI CRTX SCR SLF-TPNG W T4 STRDRIVE RCSS 12MM; 1.5MM TI CRTX SCR SLF-TPNG W T4 STRDRIVE RCSS 15MM; 1.5MM TI VAL STRUT PLATE 8 HOLES-OBLIQUE-LEFT; 1.5MM TI VAL Y-PLATE 3 HOLES HD-7 HOLES SHAFT; 2.0MM TI VAL STRAIGHT PLATE 6 HOLES; 1.5MM TI CRTX SCR SLF-TPNG W T4 STRDRIVE RCSS 11MM; 1.5MM TI CRTX SCR SLF-TPNG W T4 STRDRIVE RCSS 12MM; 1.5MM TI CRTX SCR SLF-TPNG W T4 STRDRIVE RCSS 12MM; 1.5MM TI CRTX SCR SLF-TPNG W T4 STRDRIVE RCSS 15MM; 1.5MM TI VAL STRUT PLATE 8 HOLES-OBLIQUE-LEFT; 1.5MM TI VAL Y-PLATE 3 HOLES HD-7 HOLES SHAFT; 2.0MM TI VAL STRAIGHT PLATE 6 HOLES