MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 4PK LOCKING SCRW 2025 SLFDRILL; SHOULDER IMPLANT - LOCKING SCREW

Model Number 5503-00-500

Device Problems Difficult to Insert (1316); Naturally Worn (2988)

Patient Problem Insufficient Information (4580)

Event Date 10/07/2022

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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 medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the surgeon had implanted a small baseplate with a 25mm central screw.He was looking to gain some additional compression, so he asked for the peripheral drill so he could drill for some non locking screws.The drill guide was used, and then the surgeon measured for a 20mm screw.When implanting the screw, the surgeon said that the screw went directly through the baseplate.He asked for a different 20mm non-locking screw, and that screw also went through the baseplate.At this point, the surgeon opted to implant locking screws, so he asked for the self drilling & locking screw pack.When implanting one of the locking screws, that also went through the baseplate.When the surgeon attempted to back the locking screw out, he informed me that it must have cross threaded itself into the plate, where it eventually locked into the plate.He asked that i write these implants up and have the screws returned to be analyzed.He also mentioned to me his disappointment in the ¿pick & stick¿ aspect of the peripheral screws.He said that they just don¿t seem to lock onto the t20 screwdriver the way that they should.There was no reported loosening.There was a reported surgical delay of 10-15 minutes.Doi: (b)(6) 2022.Dor: (b)(6) 2022.Affected side: left shoulder.

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 the device associated with this report was returned to depuy synthes for evaluation.Visual inspection of the returned device found a failure observed.A stripped condition is seen.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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.

• Brand Name: 4PK LOCKING SCRW 2025 SLFDRILL
• Type of Device: SHOULDER IMPLANT - LOCKING SCREW
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15698608
• MDR Text Key: 306891536
• Report Number: 1818910-2022-21591
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295549574
• UDI-Public: 10603295549574
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K212737
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/31/2022

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: 5503-00-500
• Device Catalogue Number: 550300500
• Device Lot Number: 201846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/07/2022
• Initial Date FDA Received: 10/31/2022
• Supplement Dates Manufacturer Received: 11/02/2022; 08/11/2023
• Supplement Dates FDA Received: 11/14/2022; 08/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/1999
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NON-LOCKING SCREW 20.; NON-LOCKING SCREW 20.; UNKNOWN SHOULDER METAGLENE.
• Patient Age: 63 YR
• Patient Sex: Female