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

Catalog Number UNK - PLATES: HUMERUS

Device Problem Device-Device Incompatibility (2919)

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

Event Date 05/11/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Without a valid lot number the device history records review could not be completed.This report is for one (1) unknown/unk - plate humerus/part and lot numbers are unknown.Without the specific part number the device history records review could not be completed and the udi number & g4.Pma/ 510(k) is unknown.Complainant device is not expected to be returned for manufacturer review/investigation.Initial reporter is j&j company representative.The device was not returned for investigation.The investigation was performed on images provided on the pc attachment section ¿guide.Jpg and screw.Jpg ¿.Upon analysis of the image, it is found that the attachment screw is not flush with the insertion guide and there appears to be a gap between the head of the screw and surface of the guide.However, since the product was not returned, no functional test could be performed to confirm this.The root cause of this issue cannot be determined from the information provided.A manufacturing record evaluation was not performed as the lot number could not be determined from the image provided.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.The complaint condition can be confirmed during photo investigation.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.Device history review: device lot number is unknown and dhr could not be completed.If the lot number can be confirmed in future, the dhr will be revisited.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 (b)(4) reports an event in (b)(6) as follows: it was reported that a humeral plate guide was not working, the screw does not seat in the plate properly.Concomitant device reported: unknown screwdriver (part# unknown; lot# unknown; quantity: 1).This complaint involves three (3) devices.This report is for one (1) unk - plates: humerus.This report is 2 of 3 for (b)(4).

• Brand Name: UNK - PLATES: HUMERUS
• 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: kara ditty-bovard ; 1302 wrights lane east; west chester, PA
• MDR Report Key: 11939277
• MDR Text Key: 254310002
• Report Number: 2939274-2021-02769
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK - PLATES: HUMERUS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/11/2021
• 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?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: INSERTION GUIDE; UNK - SCREWDRIVERS; UNK - SCREWS: TRAUMA