MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL SPEEDTRAP WHITE 20MM; POLYETHYLENE SUTURE

Model Number	223746
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: according to the information provided, it was reported that when the package was opened, the device fell to the border of the package and cloud be contaminated.The complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.However a photo was provided.  upon visual inspection of the photo, part of the suture was outside of the inner sterile box.Being able to affect the sterilization the unit.Therefore, the complaint reported was confirmed.Hands on analysis should provide the evidence necessary to confirm the root cause, not having the product and not having more evidence, the potential cause is not established, as the photo do not provide enough evidence to determine conclusively a root cause.  as a potential cause cannot be associated to manufacturing, therefore a manufacturing record evaluation is not required.  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.Udi: (b)(4).The expiration date is unknown.
Event or Problem Description
It was reported by affiliate via complaint submission tool that when the package of the speedtrap white short 20mm was open the sterile nurse was taking the instruction paper.When the surge was doing that, the suture of the speedtrap white short 20mm fell to the border of the package, the nurse is complaining that the suture should be hidden under the plastic of the speedtrap white short 20mm, because it is too risky when making the sterilization.No patient consequence and no surgical delay was reported.No additional information was provided.

• Brand Name: SPEEDTRAP WHITE 20MM
• Common Device Name: POLYETHYLENE SUTURE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9650084
• Report Number: 1221934-2020-00376
• Device Sequence Number: 16864919
• Product Code: GAT
• UDI-Device Identifier: 10886705027132
• UDI-Public: 10886705027132
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K161638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/21/2020

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: 223746
• Device Catalogue Number: 223746
• Device Lot Number: 4L35194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 01/30/2020
• Patient Sequence Number: 1