MAUDE Adverse Event Report: LIMACORPORATE S.P.A. BONE SCREWS; BONE SCREWS DIA. 6.5 X H. 30 MM,

Model Number 8420.15.030

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Implant Pain (4561)

Event Date 02/23/2024

Event Type  Injury  

Event Description

Shoulder revision surgery performed on (b)(6) 2024, with removal of inflammatory tissue.Previous surgery performed on (b)(6) 2024.During a clinical routine control of post-op x-rays on (b)(6) 2024, it was noticed the presence of secernent fistula at ¼ of distal surgical wound and serous secretion from the previous drainage hole.Swabs were taken to perform microbiological tests.The patient complained pain, but with an initial functional recovery of the shoulder.The following devices were explanted during the revision surgery, due to suspected infection: · smr reverse hp liner short (product code: 1365.09.010, lot.2317658 - ster.2300185) - product not sold in the us; · smr reverse hp glenosph.40 mm (product code: 1374.50.400, lot.2330270 - ster.2300284) - product not sold in the us; · bone screw ø6,5 h.30mm (product code: 8420.15.030, lot.2329829 - ster.2400003).Event occurred in italy.

Manufacturer Narrative

No pre-existing anomaly was detected by the check of the sterilization charts of the lot numbers involved, therefore we can state the devices have been regularly sterilized before being placed on the market.This is the first and only complaint received on the lot numbers involved.We will submit a final report after the final investigation.

Event Description

Shoulder revision surgery performed on (b)(6) 2024, with removal of inflammatory tissue.Previous surgery performed on (b)(6) 2024.During a clinical routine control of post-op x-rays on (b)(6) 2024, it was noticed the presence of secernent fistula at ¼ of distal surgical wound and serous secretion from the previous drainage hole.Swabs were taken to perform microbiological tests.The patient complained pain, but with an initial functional recovery of the shoulder.The following devices were explanted during the revision surgery, due to suspected infection: · smr reverse hp liner short (product code: 1365.09.010, lot.2317658 - ster.2300185) product not sold in the us.· smr reverse hp glenosph.40 mm (product code: 1374.50.400, lot.2330270 - ster.2300284) product not sold in the us.· bone screw ø6,5 h.30mm (product code: 8420.15.030, lot.2329829 - ster.2400003) event occurred in italy.

Manufacturer Narrative

No pre-existing anomaly was detected by the check of the sterilization charts of the lot numbers involved, therefore we can state the devices have been regularly sterilized before being placed on the market.This is the first and only complaint received on the lot numbers involved.Device analysis devices involved were not returned to limacorporate for further analysis.Reports of bacteriological tests, pre-operative and post-operative x-rays were available.These were sent to a medical expert for evaluation, who commented as follows: "this is a clear case of deep wound infection with cutibacterium acnes, a common problem germ.Radiographs are unremarkable.There is no sign of implant-related failure." therefore, considering that: 1) the sterilization charts of the lot numbers involved in the event have been checked without finding any pre-existing anomaly.2) according to the medical expert "this is a clear case of deep wound infection with cutibacterium acnes, a common problem germ.There is no sign of implant-related failure." we cannot with certainty determine the cause of the infection, however based on the available information received and analysis performed we can classify the event as not product related.Pms data: product family analysis: according to limacorporate pms data, we can estimate a revision rate of smr reverse prostheses due to infection of 0.08%.Based on the root cause analysis performed and according to the relevant pms data, no corrective actions required for this specific case.Limacorporate will continue monitoring the market to promptly detect any further similar issue.This is an mdr final report.

• Brand Name: BONE SCREWS
• Type of Device: BONE SCREWS DIA. 6.5 X H. 30 MM,
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: via nazionale 52; villanova, san daniele del friuli 33038
• MDR Report Key: 18958961
• MDR Text Key: 338353373
• Report Number: 3008021110-2024-00024
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• PMA/PMN Number: K172456
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 8420.15.030
• Device Lot Number: 2329829
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/08/2024
• Initial Date FDA Received: 03/22/2024
• Supplement Dates Manufacturer Received: 03/08/2024
• Supplement Dates FDA Received: 05/08/2024
• 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
• Patient Outcome(s): Required Intervention