MAUDE Adverse Event Report: 1303 GOSHEN SYNTHES USA PRODUCTS LLC UNK - PLATES: FNS; PLATE, FIXATION, BONE

Device Problem Device-Device Incompatibility (2919)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/04/2021

Event Type  Injury  

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that, the patient underwent surgery of left femur with fna implants at another hospital.The revision surgery was performed on (b)(6) 2021, for the removal of the fna implants.The surgeon tried to remove the locking screw and plate by cutting the head of the locking screw with a carbide drill.The plate was stuck to the bone firmly, and it remained in the body.A bolt and anti-rotation screw were removed.Procedure was completed successfully without any surgical delay.The patient's younger age of (b)(6) is assumed to be the primary cause of the event.Concomitant device reported: unk: nail head elements: fns antirotation.Unk: nail head elements: fns bolt.Unk: carbide drill.This report is for one (1) unk: plates: fns.This is report 2 of 2 for complaint.

Manufacturer Narrative

This report is for an unk - plates: fns/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter occupation: reporter is a j&j employee.(b)(4).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.

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: h3, h4, h6: 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 the photo/x-ray was returned to us cq for evaluation.The us cq team conducted a visual inspection of the returned device from attachment(photo_pc-001013411_karatsu sekijuji hospital (tr202100790).Pdf) visual analysis of the photo revealed that plate and the locking screw is still intact in the patient body confirming the complaint condition.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for locking screw.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.The device lot number is unknown, therefore a mre review could not be performed.If more information become available, the record will be re-assessed.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: UNK - PLATES: FNS
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): 1303 GOSHEN SYNTHES USA PRODUCTS LLC; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12925423
• MDR Text Key: 286646704
• Report Number: 2530088-2021-00027
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - CARBRIDE DRILL; UNK - NAIL HEAD ELEMENTS: FNS ANTIROTATION; UNK - NAIL HEAD ELEMENTS: FNS BOLT; UNK - SCREWS: FNS LOCKING
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR