MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 6.0MM TI HARD ROD 125MM; ORTHOSIS,SPONDYLOSTHESIS SPINAL FIXATION

Model Number	498.105
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient weight not provided for reporting.Date of event: unknown when device broke or when pain started.Additional product codes are: mni, kwp, kwq, nkb.Complainant device is not expected to be returned for manufacturer review/investigation.A review of the device history records has been requested and is currently pending completion.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
It was reported that on (b)(6) 2018, the patient had an l4-ilium posterior spinal fusion with synthes universal spinal system (uss).At an unknown time, the patient developed back pain, and also an adjacent level disc disease above the fusion.The surgeon performed the revision surgery on (b)(6) 2018, then removed all the nuts, collars, and both rods.While removing the rods, the surgeon discovered that the left rod was broken just cranial to the left s1 screw.The surgeon placed a new uss screws at l2 and l3, and contoured new rods, and connected them to the screws from l2-ilium.The surgeon did not replace any of the l4-ilium screws from the (b)(6) 2018 surgery.The procedure was successfully completed.There was no surgical delay and patient consequence.This complaint involves seven (7) devices.This report is 1 of 7 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.Device history records review was completed for part# 498.105, lot# h244050.Manufacturing location: brandywine, manufacturing date: mar 29, 2017.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Review of the archived raw material records showed that there were no issues associated with the device's raw materials that would contribute to this complaint action.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: 6.0MM TI HARD ROD 125MM
• Common Device Name: ORTHOSIS,SPONDYLOSTHESIS SPINAL FIXATION
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7916422
• Report Number: 2939274-2018-53964
• Device Sequence Number: 2338434
• Product Code: MNH
• UDI-Device Identifier: 10705034788869
• UDI-Public: (01)10705034788869
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K090605
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 498.105
• Device Catalogue Number: 498.105
• Device Lot Number: H244050
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/04/2018
• Supplement Date Received by Manufacturer: 10/05/2018
• Initial Report FDA Received Date: 09/27/2018
• Supplement Report FDA Received Date: 10/22/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR