MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 NON-LOCKING SCREW 20; SHOULDER IMPLANT - LOCKING SCREW

Model Number	5503-00-020
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/07/2022
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.
Additional 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 concomitant if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional 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 no visible damage that would indicate an implant issue.However, the reported condition was confirmed by depuy quality system.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot - a manufacturing record evaluation was performed for the finished device (b)(4), and an nc related with this issue was identified.

• Brand Name: NON-LOCKING SCREW 20
• Common Device Name: SHOULDER IMPLANT - LOCKING SCREW
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15698612
• Report Number: 1818910-2022-21590
• Device Sequence Number: 20888340
• Product Code: PHX
• UDI-Device Identifier: 10603295546849
• UDI-Public: 10603295546849
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K212737
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 5503-00-020
• Device Catalogue Number: 550300020
• Device Lot Number: 178712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2022
• Supplement Date Received by Manufacturer: 11/02/2022; 08/11/2023
• Initial Report FDA Received Date: 10/31/2022
• Supplement Report FDA Received Date: 11/14/2022; 08/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 4PK LOCKING SCRW 2025 SLFDRILL; NON-LOCKING SCREW 20; UNKNOWN SHOULDER METAGLENE
• Patient Age: 63 YR
• Patient Sex: Female