MAUDE Adverse Event Report: S.B.M. SAS SELF-LOCKING SCREW OTIS-LENGTH 60 MM; METALLIC BONE FIXATION SCREW

Catalog Number EVO9066060

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

For regularization - retrospective review / fda request.Following the analysis of the bags, the weld is compliant.The opening of the first peelable bag can be observed intentionally: there are white marks where the bags are separated for opening.These marks are only present when the welding has been done.The quality of the weld is not questioned: the welding has taken place and in accordance.No corrective action taken: the anomaly is not due to a welding defect or any quality problem with the product.

Event Description

Fnc (b)(4) - for regularization - retrospective review / fda request."otis screw box opened and not used because one of the sterile double peelable bags was poorly welded and open".

• Brand Name: SELF-LOCKING SCREW OTIS-LENGTH 60 MM
• Type of Device: METALLIC BONE FIXATION SCREW
• Manufacturer (Section D): S.B.M. SAS; zi du monge; lourdes, france 65100 ; FR 65100
• Manufacturer (Section G): S.B.M. SAS; zi du monge; lourdes, france 65100 ; FR 65100
• Manufacturer Contact: regine bareilles ; zi du monge; lourdes, france 65100 ; FR 65100
• MDR Report Key: 8639440
• MDR Text Key: 146358560
• Report Number: 3004549189-2019-00083
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K120808
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/05/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 12/19/2017
• Device Catalogue Number: EVO9066060
• Device Lot Number: 123301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/23/2013
• Initial Date FDA Received: 05/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other