MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - PLATES: CLAVICLE; PLATE, FIXATION, BONE

Catalog Number UNK - PLATES: CLAVICLE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Pain (1994); Non-union Bone Fracture (2369)

Event Type  Injury  

Event Description

This is report 1 of 3 for (b)(4).It was reported by the patient that on (b)(6) 2021, she noticed a softball sized orange spot on the worn finish of the very old cast-iron bathtub where the shoulder touched while taking a bath.According to the patient, that spot continued to be there and had not faded nor expanded.It was reported that the orange chromehidrosys from the shoulder was the result of metallosis from the plate.The patient also experienced significant pain and inflammation in the right upper chest and arm during the time the plate was attached to the clavicle that was relieved within two days after its removal.This was an allergic reaction to the plate.The patient also reported that she feels she has a metal sensitivity.She experienced constant pain and sensitivity around plate until it was removed.Patient also stated that two screws were sitting proud and caused pain when she breathed.Patient also experienced a delayed union, which required a bone stimulator.Patient declined to provided any additional information.This report is for one (1) unk plates: clavicle device.This complaint involves one (1) device.

Manufacturer Narrative

Additional narrative: 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.This report is for an unknown device/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.The lot number was unknown.Therefore, the expiration date and device manufacture date were unknown.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.

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: 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.D7: it is unknown if this single-use device was reprocessed and reused.

• Brand Name: UNK - PLATES: CLAVICLE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14251115
• MDR Text Key: 290394508
• Report Number: 2939274-2022-01545
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK - PLATES: CLAVICLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK - SCREWS: HOOK CLAVICLE; UNK - SCREWS: HOOK CLAVICLE
• Patient Outcome(s): Required Intervention