MAUDE Adverse Event Report: DEPUY IRELAND 9616671 GLOBAL UNITE COLLAR SZ 44; GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY

Catalog Number	110020200
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that the surgeon was using a global unite shoulder system to treat a humeral fracture.He wanted to use the unite fracture system with the suture collar.The set was not sterile and we had to use the implants using the unite common and anatomic instrument set.We were missing the suture collar intersowe used a femoral head impactor working around the perimeter of the humeral morse taper to seat the collar.The collar was checked for stability by the surgeon and he felt it was secure.Utilizing the impaction stand for both seating the collar and the head both pieces were secured.The global unite fracture construct in a pre assembled state was loose.
Additional Manufacturer Narrative
This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.
Additional Manufacturer Narrative
Product complaint # (b)(4).This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.

• Brand Name: GLOBAL UNITE COLLAR SZ 44
• Common Device Name: GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork IN ; EI
• MDR Report Key: 8840983
• Report Number: 1818910-2019-99630
• Device Sequence Number: 1618026
• Product Code: HSD
• UDI-Device Identifier: 10603295004233
• UDI-Public: 10603295004233
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K101996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/10/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 110020200
• Device Lot Number: 8377958
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/10/2019
• Supplement Date Received by Manufacturer: 08/07/2019; 09/03/2019
• Initial Report FDA Received Date: 07/30/2019
• Supplement Report FDA Received Date: 08/08/2019; 09/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 121