MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - BONE STAPLE: ELITE

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/12/2022

Event Type  Injury  

Event Description

It was reported on (b)(6) 2022, a revision hardware removal surgery occurred due to pain from the patient.The removal was very difficulty and resulted in an unknown harm to the patient.It is unclear if the device broke or produced fragments that could not be removed.Procedure and patient outcome is unknown.This (b)(4) (intra-op) is related to this two (b)(4) (post-op) and (b)(4) (post-op).Concomitant device reported: unk - extraction instruments: trauma (part# unknown; lot# unknown; quantity: 1).This is report 1 of 1 for (b)(4).This report is for an elite bone staple.

Manufacturer Narrative

This report is for an unknown elite bone staple/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.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.

• Brand Name: UNK - BONE STAPLE: ELITE
• Type of Device: BONE STAPLE
• 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: 14346385
• MDR Text Key: 291296533
• Report Number: 2939274-2022-01703
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2022
• 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: 04/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - EXTRACTION INSTRUMENTS: TRAUMA
• Patient Outcome(s): Required Intervention