MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US METAGLENE POSITIONER PLATE; EXTREMITY INSTRUMENTS : ALIGNMENT DEVICES

Model Number 2307-87-003

Device Problems Crack (1135); Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/16/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (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

It was reported that this was an artificial shoulder joint replacement (left shoulder) on (b)(6) 2021.The two guide pins did not go through the plate.They postoperatively confirmed that even passing a k wire (2.4mm in diameter) through the plate in question was pretty tight.There was no surgical delay and no harm to the patient.The devices were brand new and the first use when the issue occurred.

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.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: examination of the returned device can confirmed the reported event.The device is unable to assemble.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may be re-opened as necessary.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

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: b5.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Additional information received thru local letter translated stated that following: 1.Summary: results of appearance inspection, e.In the case of the pilot-scale inspection, both the pilot-scale inspection and the pin-passing inspection, both of the pilot-scale inspection and the pin-passing inspection were returned, but only a small part of the tip of the pin passed, and the content of the complaint information was reproduced.E.In the magnified appearance observation of shonin-gaf point, it was observed that part of the pore wall near the back side of the pin hole was peeling for about half a circumference, and the pore diameter seemed to be narrow.In terms of the appearance of the pins, there were scrape marks, abrasion marks, and compression marks in 1 of the 2 pins, and a slight curvature was observed.This product will be returned to the overseas manufacturer for further investigation.In japan, we will review the inspection items at the time of lending.We apologize for any inconvenience this may have caused you.Fig.1: accepted products receipt of 1 point at 7 ° rate, mosquito, kemonato, hin, and 2 points.Fig.2: 7 ° rate mosquito, monitoring, pin passing inspection it was confirmed that only a protruding part of about 5 ~ 8 mm in length fr om a 7 ° wound did not allow free pass age of any mosquito, m oth, or pin.Observation from the surface side check the separation of the hole wall near the rear surface observation from the reverse side check that part of the hole wall near the back surface is peeling for about half the circumference.Fig.4: mosquito, kemonata, pin-enlarged image 230787004 -1 (# 5379527) overall, there were no noteworthy abnormal findings including the tip.230787004 -2 (# 5382712) a bell-shaped scratch mark near the 105 ~ 115 mm length from the tip was confirmed.Three circumferential scratch marks (compression marks) were found near the tip 67 mm long.Check slight flexion from the point circumferential scrape marks near the tip 30 ~ 45 mm long were confirmed.Scrape marks and scratch marks were confirmed near the tip to 15 mm in length.

• Brand Name: METAGLENE POSITIONER PLATE
• Type of Device: EXTREMITY INSTRUMENTS : ALIGNMENT DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12556083
• MDR Text Key: 274081253
• Report Number: 1818910-2021-21604
• Device Sequence Number: 1
• Product Code: HTZ
• UDI-Device Identifier: 10603295116448
• UDI-Public: 10603295116448
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/16/2021

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
• Device Operator: Health Professional
• Device Model Number: 2307-87-003
• Device Catalogue Number: 230787003
• Device Lot Number: 5344026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/16/2021
• Initial Date FDA Received: 09/30/2021
• Supplement Dates Manufacturer Received: 10/25/2021; 10/25/2021; 11/05/2021; 11/30/2021
• Supplement Dates FDA Received: 10/28/2021; 11/07/2021; 11/23/2021; 12/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1