MAUDE Adverse Event Report: MEDLINE LEWIN; ORTHO FORCEP

Catalog Number MDS3240217

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/29/2015

Event Type  Injury  

Event Description

During left total hip arthroplasty both tips of lewin bone holder apparantly broke off.Intraoperative x-ray did not reveal metal fragments; however, post-op imaging studies showed one tip retained in patient.

• Brand Name: LEWIN
• Type of Device: ORTHO FORCEP
• Manufacturer (Section D): MEDLINE; mundelein IL 60060
• MDR Report Key: 4905725
• MDR Text Key: 15357503
• Report Number: MW5043907
• Device Sequence Number: 1
• Product Code: GEN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/06/2015

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
• Device Operator: Health Professional
• Device Catalogue Number: MDS3240217
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/06/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PATIENT UNDERWENT TOTAL HIP ARTOROPLASTY.
• Patient Age: 72 YR
• Patient Weight: 110