MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVC REPL POSITIONER SPIDER LIMB; ACCESSORIES, OPERATING-ROOM, TABLE (KIT)

Model Number	72204064
Medical Device Problem Codes	Positioning Failure (1158); Material Fragmentation (1261)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	03/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during hysteroscopy, the device was inserted at the uterine wall or fundus and tissue resection started.The device was working properly, but it appeared that upon initial resection, metallic shavings or dust came off the blade.The case was completed and tissue was resected.There was no patient injury.
Additional Manufacturer Narrative
H10 h3, h6: the reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.A review of the device history record showed there were no indications to suggest the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review found related failures.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.
Additional Manufacturer Narrative
The device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection was performed on the product and no complaint related issues were noted.A functional evaluation revealed that the unit failed the 50 pound weight test.The unit had oil within the bimba tube housing and on the bimba cylinder.After pressurization, there was also excess oil noted on the dumbbell and distal joints.The piston migration was checked and determined to be at 2.10 inches, which is indicative of hydraulic fluid loss.The complaint was confirmed and the root cause has been determined to be excessive oil loss caused by a bad seal within the amplifier piston and oil loss from seal failures at the dumbbell and distal joints.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review found related failures.This failure mode will be trended to assess for any necessary corrective actions.
Event or Problem Description
It was reported that during a shoulder surgery the positioner spider limb arm was not holding pressure.The procedure was successfully completed without delay using a back-up device.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
Smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.H11: re-submit mdr as follow-up 001.

• Brand Name: SVC REPL POSITIONER SPIDER LIMB
• Common Device Name: ACCESSORIES, OPERATING-ROOM, TABLE (KIT)
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• MDR Report Key: 9910004
• Report Number: 1643264-2020-00189
• Device Sequence Number: 14308484
• Product Code: FWZ
• UDI-Device Identifier: 10884521744097
• UDI-Public: 10884521744097
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/31/2020

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 Expiration Date: 04/17/2020
• Device Model Number: 72204064
• Device Catalogue Number: 7210569S
• Device Lot Number: 4732892
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2020
• Initial Date Received by Manufacturer: 03/06/2020
• Supplement Date Received by Manufacturer: 03/09/2020; 05/04/2020; 05/28/2020
• Initial Report FDA Received Date: 04/01/2020
• Supplement Report FDA Received Date: 04/02/2020; 05/07/2020; 05/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1