MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL STERILE LATARJET SCREW, 40MM; POLYMETHYLMETHACRYLATE BONE CEMENT

Model Number 288228

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/23/2019

Event Type  malfunction  

Manufacturer Narrative

Device is not distributed in the united states, but is similar to device marketed in the usa.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, that when opening the implant box (sealed and hermetic), the nurse discovered the screw was missing inside the package.There was no clinical consequence this report is for one (1) sterile latarjet screw, 40mm.This is report 1 of 1 for (b)(4).

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.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Additional information: event description udi: (b)(4).

Event Description

Additional information received from the affiliate reported the secondary packaging was a blister and the device package was sealed.It was also reported the shoulder surgery under arthroscopy was successfully completed and patient harm was not reported.The affiliate reported the procedure was completed with another device and surgical intervention is not planned.

Event Description

Additional information received: name of the procedure: shoulder surgery under arthroscopy.No impact to the patient as another device was opened.The surgery was successfully completed.

Manufacturer Narrative

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.Device was used for treatment, not diagnosis.Additional narrative: device evaluated by mfr: the complaint device package is not being returned, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.One possible root cause of the reported problem could be improper packaging.However without the return of the complaint device package, and no further information provided we cannot determine a definitive root cause.A manufacturing record evaluation was performed for the finished device lot number (3922293), and no non-conformances were identified.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.Device history lot: product code: 288228, lot number: 3922293.Anomalies or discrepancies (non-conformance) : none device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: STERILE LATARJET SCREW, 40MM
• Type of Device: POLYMETHYLMETHACRYLATE BONE CEMENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9218465
• MDR Text Key: 206751639
• Report Number: 1221934-2019-59149
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 10886705027057
• UDI-Public: (01)10886705027057
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: 288228
• Device Catalogue Number: 288228
• Device Lot Number: 3922293
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/22/2019
• Patient Sequence Number: 1