MAUDE Adverse Event Report: DEPUY SYNTHES, INC HOHMANN RETRACTOR

Catalog Number 03.100.110

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/19/2020

Event Type  malfunction  

Event Description

During total shoulder resurfacing surgery, the hohmann retractor cat # 03.100.110 lot 6714770 broke and the tip was lodged in the patient's right proximal humerus.Surgeon attempted to retrieve multiple times under fluoroscopy.Decided to leave the stainless-steel broken tip in place to maintain the integrity of humerus.Surgery completed as planned with no additional interventions.Patient was informed and local dept of public health notified.Patient is doing well with full range of motion.Depuy synthes rep notified.Fda safety report id # (b)(4).

• Brand Name: HOHMANN RETRACTOR
• Type of Device: RETRACTOR
• Manufacturer (Section D): DEPUY SYNTHES, INC
• MDR Report Key: 10958502
• MDR Text Key: 220246636
• Report Number: MW5098223
• Device Sequence Number: 1
• Product Code: GAD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.100.110
• Device Lot Number: 6718770
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 66 YR