MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS HUMERAL STEM TRIAL, 14MM; TITAN TOTAL SHOULDER INSTRUMENTS

Catalog Number TRL-0920-025-14

Device Problem Break (1069)

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 1 of 2 reports: same patient, same procedure, different products.Other mfg report #:1651501-2017-00041.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 november 9, 2017.Results: dhr review; the manufacturing records for product id trl-0920-025-14 could not be reviewed due to the lot number not provided by the complainant for the reported incident alleged.Complaints history; a review of complaint records during the last 5 years found 16 humeral stem trial complaints reported for breakage.During that period of time, there have been approximately 3529 tss surgeries reported.This represents a complaint rate of 0.45% (16/3529) as some of the reported events were associated with a serious severity level, this indicates an adverse trend.Conclusion: at this time, the root causes for this incident could not be determined with the available information.

• Brand Name: HUMERAL STEM TRIAL, 14MM
• 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: 6982709
• MDR Text Key: 90390036
• Report Number: 1651501-2017-00040
• 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
• Report Date: 10/19/2017

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: TRL-0920-025-14
• Was Device Available for Evaluation?: No
• 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: 11/09/2017
• Supplement Dates FDA Received: 11/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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