MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SPEED COMPRESSION IMPLANT KIT 09X07X07MM; STAPLE, FIXATION, BONE

Model Number SE-0907

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Manufacturer Narrative

Occupation: reporter is a j&j sales representative.The device has been received, the investigation is in progress, 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 while restocking the tote, it was noticed that the staple of the speed compression implant kit was not connected to the handle.There was no patient involvement.This report is for one (1) speed compression implant kit 09x07x07mm.This is report 1 of 1 for complaint (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: h3, h6: part: se-0907.Synthes lot: bse180780.Supplier lot: bse180780.Expiration date: august 13, 2023.Release to warehouse date: august 13, 2018.Supplier: (b)(4).No nonconformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Visual inspection: the speed compression implant kit 09x07x07 mm was returned and received at us customer quality (cq).Upon visual inspection, it was observed that the implant fell apart from its inserter and the implant is still inside the packaging.The packaging of the kit showed no defect externally.No other abnormalities were identified.Functional test: functional test cannot be performed from the received condition of the device.Dimensional inspection: the premature deployment on speed implants is a known issue.It has been determined that the most probable root cause for this type of issue is the packaging design, with transit/handling being a contributing factor.So the dimensional inspection was not performed.Document review: rev6 speed implant kit.Investigation flow: the overall complaint condition of the returned device was confirmed as implant fell apart form the inserter.The most probable cause for the implant missing is premature deployment, which caused the implant to fall out of the package.Premature deployment on speed implants is a known issue.It has been determined that the most probable root cause for this type of issue is the packaging design, with transit/handling being a contributing factor.Nonetheless, the root cause for this occurrence cannot be confirmed based on the information provided on this complaint.Relevant actions have been taken to address the issue.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: SPEED COMPRESSION IMPLANT KIT 09X07X07MM
• 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: 11088257
• MDR Text Key: 224132155
• Report Number: 2939274-2020-05745
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 00810633020104
• UDI-Public: (01)00810633020104
• 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
• Type of Report: Initial,Followup
• Report Date: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/13/2023
• Device Model Number: SE-0907
• Device Catalogue Number: SE-0907
• Device Lot Number: BSE180780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Date Manufacturer Received: 01/06/2021
• Patient Sequence Number: 1