MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 GLOBAL UNITE STD STEM SZ 8; GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEMS

Model Number 1100-08-100

Device Problem Device-Device Incompatibility (2919)

Patient Problems Not Applicable (3189); No Code Available (3191)

Event Date 05/18/2020

Event Type  malfunction  

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 Description

Intraoperatively the centric epiphysis sz.1 did not fit into the stem.Another stem was used and connected with the epiphysis without issues.Surgical delay < 15 minutes, no adverse consequences for patient.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.¿.

Manufacturer Narrative

Product complaint #
=
>(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative:  added: d10, e1 (facility name).Corrected: h3, h6 (patient).H6 patient code: no code available (3191) was used to capture prolonged surgery and insufficient information.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : evaluation of the returned device confirmed the reported event.The device was manufactured on 13-june-2016.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : product code 110008100, work order (b)(4) was manufactured on 13-jun-2016.(b)(4) parts were manufactured per specification and all raw materials met specification.(b)(4) parts were scrapped.1x a050 (deep tool marks).1x a564 (part mark 2d mark scrap).Both are unrelated to the failure mode of this pc.No parts were reworked.There was no non-conformance (nc) associated with this lot.

• Brand Name: GLOBAL UNITE STD STEM SZ 8
• Type of Device: GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEMS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10098170
• MDR Text Key: 192740248
• Report Number: 1818910-2020-12791
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295004042
• UDI-Public: 10603295004042
• Combination Product (y/n): N
• PMA/PMN Number: K101996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1100-08-100
• Device Catalogue Number: 110008100
• Device Lot Number: 8321744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2020
• Date Manufacturer Received: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GLOBAL UNITE STD STEM SZ 8; UNKNOWN SHOULDER HUMERAL STEMS