MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL LOCKING SCREW - L34; POLYAXIAL SHOULDER LOCKING SCREW

Catalog Number	04.01.0165
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Preliminary investigation performed by r&d (b)(4): as reported by the sales representative, the insertion of the screw was totally carried out with the "glenoid polyaxial screwdriver - non-retentive" (ref.(b)(4)).The use of this instrument instead of the "polyaxial screwdriver - modular tip" (ref.(b)(4)), prevents the petals from being captured, exposing the head to an increased risk of breakage.Batch review performed on 29 apr 2019: lot 174752: (b)(4) items manufactured and released on 30-jan-2018.Expiration date: 2023-01-16.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
During the primary surgery the head of the screw got damaged when the surgeon tried to insert it with the screwdriver.The screw was further damaged extracting it with a pincer.The bone was sclerotic.The surgery was completed successfully using a new screw.No critical delay during the surgery and no parts fell into the patient.The "glenoid polyaxial screwdriver - non-retentive" (ref.(b)(4)) was used to insert the screw.
Additional Manufacturer Narrative
On may 09th 2019 we discovered that the implant reference reported in the initial report was not correct.The correct reference is 04.01.0165.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL LOCKING SCREW - L34
• Common Device Name: POLYAXIAL SHOULDER LOCKING SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8560456
• Report Number: 3005180920-2019-00320
• Device Sequence Number: 11518226
• Product Code: PHX
• UDI-Device Identifier: 07630040706490
• UDI-Public: 07630040706490
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2019

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 Expiration Date: 01/16/2023
• Device Catalogue Number: 04.01.0165
• Device Lot Number: 174752
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2019
• Supplement Date Received by Manufacturer: 04/01/2019
• Initial Report FDA Received Date: 04/29/2019
• Supplement Report FDA Received Date: 06/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 42 YR