MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS STEM TRIAL HANDLE; TITAN TOTAL SHOULDER INSTRUMENTS

Catalog Number HDL-0920-043-001

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

Patient Problems Injury (2348); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

To date the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based on the reported information.

Event Description

The 2 of 2 reports: same patient, same procedure, different products.Other mfg report #: 1651501-2017-00040.It was reported that during the preparation of the humeral canal for a reverse shoulder arthroplasty, the humeral stem trial broke off the stem trial handle.This case was a revision of a primary from the previous week that had dislocated.The implanted stem was a size 13, but the surgeon sized up to a 14 for the reverse to increase the body height.The surgeon had to make anosteotomy to be able to remove the impacted stem trial.The event lead to 90 minutes surgical delay.

Manufacturer Narrative

Integra has completed their internal investigation on february 15, 2018.Evaluation of returned device; the humeral stem trial arrived in two pieces.The stem was broken at the threads where it is inserted into the receiving threads of the impact handle.The broken portion remained lodged in the insert portion of the handle.Dhr review; no abnormalities or nonconformances were identified that could have caused or contributed to the complaint.Conclusion: the cause of the device breakage may have resulted from the instrument design was unable to withstand repeated heavy impact loads.The breakage of the humeral stem trial is consistent with previous complaints of this nature.The most probable root cause may have resulted from the user¿s technique, such as mallet selection used for impaction or material/heat treatment combination resulting in a failure after repeated impacts.Patient physiology, such as dense or hard bone may also have contributed to the breakage in the device.A contributing factor may be that the instrument design is not optimal to withstand repeated heavy impact loads during surgery which would lead to the breakage of the device over repeated uses.

Manufacturer Narrative

Integra has completed their internal investigation on november 17, 2017.Results: dhr review; the lot number for the humeral stem handle was not known at the time of the complaint initiation, therefore the manufacturing records could not be identified and a dhr review could not be conducted.Complaints history; a review of complaint records during the last 5 years found 9 humeral stem trial handle complaints reported for breakage.During that period of time, there have been approximately 3529 tss surgeries reported.This represents a complaint rate of (b)(4).Conclusion: at this time, the root causes for this incident could not be determined with the available information.Based upon previous incidents, the cause of the device breakage may have resulted from the instrument design was unable to withstand repeated heavy impact loads.Other factors may have included the user¿s technique, such as mallet selection for impaction or material/heat treatment, or a combination of both resulting in a failure after repeated impacts.Patient physiology, such as dense or hard bone may also have contributed to the breakage in the device.Breakage may have occurred due to use of the device over time.

• Brand Name: STEM TRIAL HANDLE
• Type of Device: TITAN TOTAL SHOULDER INSTRUMENTS
• Manufacturer (Section D): ASCENSION ORTHOPEDICS; 8700 cameron road #100; 8700 cameron road #100; austin TX 78754
• Manufacturer (Section G): ASCENSION ORTHOPEDICS; 8700 cameron road #100; austin TX 78754
• Manufacturer Contact: sonia irizarry ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6982708
• MDR Text Key: 90390186
• Report Number: 1651501-2017-00041
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Device Operator: Health Professional
• Device Catalogue Number: HDL-0920-043-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/19/2017
• Initial Date FDA Received: 10/27/2017
• Supplement Dates Manufacturer Received: 11/17/2017; 02/15/2018
• Supplement Dates FDA Received: 11/20/2017; 03/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention