MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CANNULATED CONNECTING SCREW; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 03.037.010

Device Problems Device-Device Incompatibility (2919); Material Integrity Problem (2978)

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

Event Date 09/29/2021

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a j&j employee.Without a lot number the device history records review could not be completed.Product was not returned.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) 2021 during a trauma procedure, the surgeon experienced difficulty removing the cannulated connecting screw after insertion.Upon completion, the connecting screw threads were found to be damaged.The ball hex screwdriver was damaged while removing the connecting screw.There was a surgical delay of (15) minutes.The procedure was successfully completed by using pliers to help remove the bolt.No fragments were generated.There was no patient consequence.This report is for (1) cannulated connecting screw.This is report 2 of 2 for (b)(4).

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d9 h3, h6: a product investigation was conducted.Visual inspection: the connecscr f/insertion handle (part# 03.037.010, lot# l278492) was returned and received at us cq.Upon visual inspection at cq, it is observed that the hexagonal shape of the head was deformed.No other issue was observed with the return device.Functional test: a functional assessment was performed on the complaint device with the returned mating device scr-driver-hex w/spheric-head ø8 (p/n: 357.515, lot number: 5373996).The devices were hard to disassemble, the deformed shape of the head might have contributed to the reported device interaction condition.Dimensional inspection: feature: head outer diameter was measured and found to be confirming per relevant drawing.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed.No design issues or discrepancies were identified.Investigation conclusion: this complaint is confirmed as the devices were hard to disassemble.The potential cause for the device interaction condition could be due to deformed head.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.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.H3, h6: a device history record (dhr) review was conducted: part: 03.037.010.Lot: l278492.Manufacturing site: hägendorf.Release to warehouse date: 28.April 2017.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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: CANNULATED CONNECTING SCREW
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12704247
• MDR Text Key: 278596815
• Report Number: 2939274-2021-06326
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819642362
• UDI-Public: (01)07611819642362
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K131548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.037.010
• Device Lot Number: L278492
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2017
• 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
• Treatment: SCR-DRIVER-HEX W/SPHERIC-HEAD Ø8; SCR-DRIVER-HEX W/SPHERIC-HEAD Ø8