MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - BME; STAPLE, FIXATION, BONE

Catalog Number UNK - BME

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: 510k: this report is for an unknown bme device/unknown lot.Part and lot numbers are unknown; udi number is unknown.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.Initial reporter is synthes sales representative 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 Description

It was reported that the patient underwent an unknown procedure on an unknown date, due to osteotomy tibia, hardware removal and staples did not achieve enough compression at the osteotomy site.Patient had reoperation due to hardware removal and ttc arthrodesis.Patient was readmitted at 49 days post-op for hardware failure.Known post-operative complications reported.Patient outcome is unknown.No further information is available.This complaint involves one (1) device.This report is for one (1) unk ¿ bme device 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.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.G4: date of awareness for initial report should be august 19, 2021.

Event Description

This report is for an unknown bone staple.

• Brand Name: UNK - BME
• Type of Device: STAPLE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12347451
• MDR Text Key: 267431394
• Report Number: 8030965-2021-06953
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,study
• Type of Report: Initial,Followup,Followup
• Report Date: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK - BME
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention