MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 6.5MM CANNULATED SCREW 32MM THREAD 85MM; ORTHOPAEDIC BONE SCREW, NON-BIOABSORBABLE, NON-STERILE

Model Number	208.439
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
This is report 2 of 2 for (b)(4).It was reported by the customer that postoperatively to an unknown surgery initially performed on (b)(6) 2021, a patient underwent hardware removal of a screw device on (b)(6) 2022, (b)(6) 2022 due to screw prominence as it came off of the pelvis.According to the report, the device was removed without complication.It was reported that the implant was in the washer device that was left in the patient and not retrieved.It was reported that the patient was doing fine postoperatively.No additional information was provided.This report is for one (1) 6.5mm cannulated screw 32mm thread 85mm device.This complaint involves two (2) devices.
Additional Manufacturer Narrative
If the information is unknown, not available or does not apply, the section/field of the form is left blank.Complainant part is not expected to be returned for manufacturer review/investigation.The lot number was unknown.Therefore, the expiration date and device manufacture date were unknown.Reporter is a j&j sales representative.Without a lot number the device history records review could not be completed.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and 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.

• Brand Name: 6.5MM CANNULATED SCREW 32MM THREAD 85MM
• Common Device Name: ORTHOPAEDIC BONE SCREW, NON-BIOABSORBABLE, NON-STERILE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK RARON (CH); kanalstrasse west 30; raron 3942 ; SZ 3942
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14245626
• Report Number: 2939274-2022-01526
• Device Sequence Number: 4398726
• Product Code: HWC
• UDI-Device Identifier: 10886982149442
• UDI-Public: 10886982149442
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 208.439
• Device Catalogue Number: 208.439
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2022
• Initial Report FDA Received Date: 04/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 95 KG