MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC BME SPEED(TM) IMPLANT KIT 9 X 7 MM; STAPLE,FIXATION,BONE

Model Number	SE-0907
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is a j&j employee.The device was 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 or Problem Description
It was reported that on (b)(6) 2020, during routing inspection, a bme speed implant kit staple appeared to have accidentally deployed inside the packaging.There was no patient and surgical procedure involvement.This report is for one (1) bme speed(tm) implant kit 9 x 7 mm.This is report 1 of 1 for (b)(4).
Additional 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: g1 h3, h6: part: se-0907.Synthes lot: bse180504.Supplier lot: bse180504.Release to warehouse date: july 24, 2018.Supplier: (b)(4).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 bme speed implant kit 9 x 7 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.Relevant actions have been taken to address the issue.Nonetheless, the root cause for this occurrence cannot be confirmed based on the information provided on this complaint.No manufacturing related issue was identified and/or confirmed.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 9 X 7 MM
• Common Device Name: STAPLE,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11156477
• Report Number: 2939274-2021-00227
• Device Sequence Number: 4069277
• Product Code: JDR
• UDI-Device Identifier: 00810633020104
• UDI-Public: (01)00810633020104
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K142292
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2020

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
• Operator of Device: Health Professional
• Device Model Number: SE-0907
• Device Catalogue Number: SE-0907
• Device Lot Number: BSE180504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2020
• Initial Date Received by Manufacturer: 12/16/2020
• Supplement Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 01/12/2021
• Supplement Report FDA Received Date: 02/04/2021
• Patient Sequence Number: 1