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

Model Number 03.010.446

Device Problem Material Twisted/Bent (2981)

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

Event Date 11/28/2020

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is jnj representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing 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.

Event Description

It was reported that on (b)(6) 2020, the compression device for suprapatellar, extractor, connecting screws and extraction screw were stripped, trocars were bent along with the wire guides, blue handle, black knob broke off, along with buttons on the side to protection sleeve.The surgeon was aggressive and over-torqued products leading to stripping and bending of products.A new set brought into the room.There were 10 minutes of surgical delay.It is unknown if the surgery successfully completed.No patient consequence.This complaint 11 devices.This report is for (1) extraction screw/m8 for suprapatellar.This report is 3 of 8 for (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: 11072163
• MDR Text Key: 223717042
• Report Number: 2939274-2020-05696
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10886982068880
• UDI-Public: (01)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,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/28/2020

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
• Device Operator: Health Professional
• Device Model Number: 03.010.446
• Device Catalogue Number: 03.010.446
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2020
• Initial Date FDA Received: 12/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1