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

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/08/2022

Event Type  malfunction  

Event Description

It was reported that during a procedure on (b)(6) 2022, the cage in question was shorter than the surgeon expected.The procedure was able to continue still using the implant, and the surgery was completed successfully with little delay.There was no adverse patient impact.No further information is available.This report is for a trumatch graft cage-long bone >5cm to 10cm/sterile.This is report 1 of 1 for (b)(4).

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.Additional narrative: device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or 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.No nrs were generated during production of lot number: 900p362.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.Part number: sd900.501s, lot number: 900p362, supplier lot number: n/a, manufacture date or release to warehouse date: 06/30/2022, expiration date: 01/31/2021.Supplier/manufacture site: (b)(6).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: TRUMATCH GRAFT CAGE-LONG BONE >5CM TO 10CM/STERILE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WILSON DRIVE MANUFACTURING; 1230 wilson drive; west chester PA
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA ; 3035526892
• MDR Report Key: 15355786
• MDR Text Key: 305610161
• Report Number: 2939274-2022-03407
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982262479
• UDI-Public: (01)10886982262479
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180821
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SD900.501S
• Device Catalogue Number: SD900.501S
• Device Lot Number: 900P362
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Sex: Female
• Patient Weight: 92 KG