MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC BME SPEED(TM) IMPLANT KIT 13 X 12 MM; STAPLE,FIXATION,BONE

Model Number SE-1312

Device Problem Difficult to Advance (2920)

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

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is jnj representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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

It was reported that on an unknown date, upon opening bme speed staple, it was discovered that the staples were already compressed, so we went to try a different one and the same thing happened with 3 staple implant kits.Bilateral bunion corrections.There was no surgical delay.The procedure successfully completed.No patient consequences.This complaint involves 3 devices.This report is for (1) bme speed(tm) implant kit 13 x 12 mm.This report is 1 of 3 for (b)(4).

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: d9, d10.H3, h6: a product investigation was completed: upon visual inspection no damage was noted on the implant that would contribute to the complaint condition.A functional test could not be performed as the device was not returned in its original packaging to see if the staple was already deployed/compressed.No dimensional inspection was performed as no issues were noted on the staple and is unconfirmed.Based on the review of the drawings, no design issues contributing to relevant complaint condition were identified.There is no indication that a design or manufacturing issue contributed to the complaint as it was unconfirmed.No new malfunctions were observed during the course of this investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: BME SPEED(TM) IMPLANT KIT 13 X 12 MM
• Type of Device: STAPLE,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11401897
• MDR Text Key: 234426577
• Report Number: 2939274-2021-01129
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 00810633022016
• UDI-Public: (01)00810633022016
• Combination Product (y/n): N
• PMA/PMN Number: K142292
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SE-1312
• Device Catalogue Number: SE-1312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2021
• Initial Date Manufacturer Received: 02/08/2021
• Initial Date FDA Received: 03/02/2021
• Supplement Dates Manufacturer Received: 03/12/2021
• Supplement Dates FDA Received: 03/31/2021
• Patient Sequence Number: 1
• Treatment: SPEED COMPRESSION IMPLANT KIT 13X10X10MM; SPEEDTRIAD COMPRESSION IMPLANT KIT 20X15X08MM