MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SPIDER CAPITAL; SPIDER 2 TENET 7615

Catalog Number 72203299

Device Problem Component Falling (1105)

Patient Problem Head Injury (1879)

Event Date 05/08/2015

Event Type  Injury  

Event Description

The spider2 loosened up in the middle of the procedure, dropped, and hit a nurse on the head.Customer said the battery was fine and fully charged.The nurse who was injured required medical attention at the reporting facility.The customer says they do 3-4 shoulder surgeries every week and use the spider for each one.They have had this unit approximately one year.The sales rep indicated he went into the account with a replacement spider device and was told by two staff members that the nurse who was injured had undergone a cat scan.Staff member stated there was no broken skin and as far as they were aware, no follow up treatment is scheduled at this time.Sales rep.Did not speak to the nurse himself as she had already left for the day.Additional information received indicates on the day of the incident ((b)(6) 2015), the nurse went home early and also the following monday on (b)(6) 2015, she left early as well.

Manufacturer Narrative

Although anticipated, the device has not been received for analysis.(b)(4).

Manufacturer Narrative

One customer tenet spider2, patient limb positioner ((b)(4)), was received on (b)(6) 2015 and confirmed to be serial number (b)(4) as reported by the complaint.Product passed visual inspection with no physical damage to the unit observed.Complaint of sudden pressure loss could not be confirmed.The unit was functionally tested with pressurization cycles and long-term pressurization; however, the results of the testing determined the unit to be functionally acceptable.Both batteries accompanying the unit were confirmed to be functional and contained an adequate charge upon receiving.After disassembly of the device, a migration check was performed to assert that no oil loss or low levels of oil contributed to the reported complaint.Overall, no problems were found.No further investigation is warranted at this time.A review of the device history record was performed which confirmed no inconsistencies.(b)(4).

• Brand Name: SPIDER CAPITAL
• Type of Device: SPIDER 2 TENET 7615
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• Manufacturer Contact: jim gonzales ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 4822519
• MDR Text Key: 16080791
• Report Number: 1643264-2015-00021
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72203299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other