MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG CS/CSL/GERADSCHAFT-PLUS EXTRACT.SCREW M6; OSTEOTOME

Model Number	75002165
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that these cs/csl/geradschaft-plus extract.Screw m6 were found defective.One was found to be bent ((b)(6)) and a thread came off from the other one ((b)(6)).It was reported that the failures occurred during use and a change in surgical technique was necessary in order to complete the procedure.Section was used to retrieve metal shavings.A delay of 30 min or less was reported.
Additional Manufacturer Narrative
It was reported that one m6 extraction screw was found bent prior to surgery.Therefore, another m6 extraction screw was used.However, that second one broke during surgery.In order to remove the stem, a third unknown device was used, which was reported to be heavily worn after the procedure.This investigation focused on the device which was found bent prior to surgery.The device was not used for the reported surgery and did not lead to any patient harm.The device, used in treatment, was returned for investigation.It can be confirmed that the thread if the m6 extraction screw is bent.Further signs of use are visible.The production documentation of the returned device was reviewed, however there were no deviations found.Several further complaints were reported for the batch in scope, however regarding the size of the batch, the need for further actions is not indicated.The failure modes and the severity are covered through our risk management files.According to document "processing (cleaning, disinfection and sterilization) of instruments from smith & nephew orthopaedics ag" (lit.N°03389-en 1363 v3 11/19), all instruments must be inspected and controlled for proper functioning after cleaning/disinfection.The failure mode of the returned device can be confirmed, the root cause is attributed to a design issue.To date, based on the available information, the need for further actions is not indicated.Smith and nephew will monitor the devices for further similar issues.The returned device will be discarded.

• Brand Name: CS/CSL/GERADSCHAFT-PLUS EXTRACT.SCREW M6
• Common Device Name: OSTEOTOME
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11347069
• Report Number: 9613369-2021-00073
• Device Sequence Number: 19862927
• Product Code: HWM
• UDI-Device Identifier: 07611996056563
• UDI-Public: 07611996056563
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 75002165
• Device Catalogue Number: 75002165
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2021
• Initial Date Received by Manufacturer: 01/26/2021
• Supplement Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 02/18/2021
• Supplement Report FDA Received Date: 05/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention