MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TRUMATCH GRAFT CAGE-LONG BONE >5CM TO 10CM/STERILE; PLATE, FIXATION, BONE

Model Number	SD900.501S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Part number: sd900.501s, lot number: 79p4518, supplier lot number: n/a, manufacture date or release to warehouse date: december 1, 2020, expiration date: january 31, 2021, supplier/manufacture site: (b)(4).No ncrs were generated during production of lot number 79p4518.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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.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) 2021, during the implantation of the cage, the cage broke.The cage appeared to be brittle.The surgeon opened a second cage, and the second cage broke.There was a surgical delay of thirty (30) minutes.The procedure was completed successfully.There was no consequence to the patient.This report involves one (1) trumatch graft cage-long bone >5cm to 10cm/sterile.This is report 2 of 2 for (b)(4).

• Brand Name: TRUMATCH GRAFT CAGE-LONG BONE >5CM TO 10CM/STERILE
• 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: 11240343
• Report Number: 2939274-2021-00514
• Device Sequence Number: 17125472
• Product Code: HRS
• UDI-Device Identifier: 10886982262479
• UDI-Public: (01)10886982262479
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K180821
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/07/2021

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 Expiration Date: 01/31/2021
• Device Model Number: SD900.501S
• Device Catalogue Number: SD900.501S
• Device Lot Number: 79P4518
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/07/2021
• Initial Report FDA Received Date: 01/27/2021
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Weight: 65