MAUDE Adverse Event Report: ETHICON, INC. ETHIBOND EXCEL; SUTURE, ABSORBABLE, NATURAL

Lot Number KHJ011

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/11/2017

Event Type  malfunction  

Event Description

During a left total hip arthroplasty a piece of an ethicon needle broke.A small fragment was intentionally left in the patient's bone due to associated risk for removal.Patient did well postoperatively and was discharged home per standard of care.

• Brand Name: ETHIBOND EXCEL
• Type of Device: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON, INC.; route 22 west; p.o. box 151; somerville NJ 08876
• MDR Report Key: 6544664
• MDR Text Key: 74515251
• Report Number: 6544664
• Device Sequence Number: 1
• Product Code: GAL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/20/2017

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
• Device Operator: Physician
• Device Expiration Date: 10/31/2021
• Device Lot Number: KHJ011
• Other Device ID Number: 7.0 METRIC, 30", V-40, MB46
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/20/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 04/20/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR