MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ELITE S IMPL KIT/2 LEGS 18 X 15 X 15/-S; STAPLE, FIXATION, BONE

Model Number	EL-1815S2
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthes reports an event in the usa as follows: it was reported on an unknown date, during the surgery, the elite s implant kit staple fell off of the inserter prior to insertion causing the surgeon to ask for another staple to be opened since they could not be reloaded easily.There was a surgical delay of 5 minutes.The procedure was completed successfully.There was no patient consequence reported.This complaint involves one(1) device elite s impl kit/2 legs 18 x 15 x 15/-s.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.The investigation could not be completed; no conclusion could be drawn, as no product was received.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: ELITE S IMPL KIT/2 LEGS 18 X 15 X 15/-S
• Common Device Name: STAPLE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 13966157
• Report Number: 2939274-2022-01134
• Device Sequence Number: 14494195
• Product Code: JDR
• UDI-Device Identifier: 07612334226655
• UDI-Public: (01)07612334226655
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K150125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/31/2022

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: EL-1815S2
• Device Catalogue Number: EL-1815S2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2022
• Initial Report FDA Received Date: 03/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown