MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC EXTRACTION SCREW/M8 FOR SUPRAPATELLAR; EXTRACTOR

Model Number 03.010.446

Device Problem Corroded (1131)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Reporter is a j&j employee.Visual inspection of the complaint device identifies that the connecting thread is damaged.No dimensional inspection performed due to post manufacturing damage.Drawing/specification review: following drawings were reviewed: extraction screw.Overall complaint confirmed? no.Conclusion: the complaint condition is not confirmed.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot, part: 03.010.446.Lot: f-12432 manufacturing site: (b)(4).Supplier: (b)(4).Release to warehouse date: june 27, 2011.Due to the age of more than 9 years of this device a wear or use related root cause is the most likely reason of the complained malfunction.Per franchise complaint product investigation procedure (b)(4) is for complaints for which a non-manufacturing related probable cause has been identified no mre review required.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

It was reported that on an unknown date during inspection, the extraction screw for supratellar was noted to be corroded.There was no patient or procedure involvement.This report is for one (1) extraction screw/m8 for suprapatellar.This is report 1 of 1 for pc (b)(4).

• Brand Name: EXTRACTION SCREW/M8 FOR SUPRAPATELLAR
• Type of Device: EXTRACTOR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11274731
• MDR Text Key: 247278409
• Report Number: 2939274-2021-00663
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10886982068880
• UDI-Public: 10886982068880
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/15/2021

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 Model Number: 03.010.446
• Device Catalogue Number: 03.010.446
• Device Lot Number: F-12432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2021
• Initial Date FDA Received: 02/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1