MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SPEED COMPRESSION IMPLANT KIT 15X15X15MM; STAPLE, FIXATION, BONE

Model Number	SE-1515
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 sales representative.A product investigation was conducted.Visual inspection: the speed compression implant kit 15x15x15mm (p/n: se-1515, lot number: bmese160254) was received at us cq.Visual inspection of the complaint device showed the device had fallen apart inside the packaging.Functional test: a functional assessment was not performed on the complaint device since it was in the original packaging.The complaint was able to be confirmed.Dimensional inspection: a dimensional inspection was not performed since it was not applicable to the complaint condition.Document/specification review: relevant drawings were reviewed.No design issues or discrepancies were identified.Investigation conclusion: this complaint is confirmed as the device had fallen apart inside the packaging.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.A device history record (dhr) review was conducted: part # se-1515, synthes lot # bmese160254, supplier lot # 1605120077 , expiration date: 15 jul 2021, release to warehouse date: 19 aug 2016, supplier: (b)(4).No ncr's 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.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 an unknown date, the staple of the speed compression implant kit fell off of the inserter while still in the packaging.The issue happened during shipping while at the office.There was no patient involvement reported.This report is for one (1) speed compression implant kit 15x15x15mm.This is report 1 of 1 for complaint (b)(4).

• Brand Name: SPEED COMPRESSION IMPLANT KIT 15X15X15MM
• 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: 11866548
• Report Number: 2939274-2021-02499
• Device Sequence Number: 1099689
• Product Code: JDR
• UDI-Device Identifier: 00810633020173
• UDI-Public: (01)00810633020173
• 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
• Report Date (Section B): 03/29/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/15/2021
• Device Model Number: SE-1515
• Device Catalogue Number: SE-1515
• Device Lot Number: BMESE160254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 05/21/2021
• Patient Sequence Number: 1