MAUDE Adverse Event Report: AESCULAP AG ENNOVATE POLYAX.SCREW 7.5X50MM CANULATED; IMPLANTS POSTERIOR STABILISATI

Model Number	SY645TS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported to aesculap ag that an ennovate polyax.Screw 7.5x50mm canulated (part # sy645ts) was used during a procedure performed on an unknown date.According to the complainant, the screwdriver loosened the screw despite the separate tightening of the screw when screwing the ennovate screws.When unscrewing both screws, the screw head came off the set screw without much effort.The complaint device has been returned to the manufacturer for evaluation.A significant surgical delay was reported.However, no patient complications were reported as a result of the event.Although requested, additional information has not been made available.The malfunction is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Correction/additional information: b1 + h1: updated to adverse event.B5: patient harm changed.H6: updated codes.Investigation results: visual investigation: a visual inspection of both screws were made.The body has come loose from the threaded part at both screws.The fine thread at the bottom of the body of both screws were investigated.The fine thread.Is in a proper condition at both screws.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity 3(5) x probability of occurrence 2(5)) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: based upon the investigation results, the root cause of the reported issue can be traced back to a design-related failure.The occurred effect is no failure of the product, it is construction-related (all screws with a diameter of 7.5 mm or more are screwed together clockwise of two parts and can split into two parts again when turned counterclockwise).The failure rate was checked and was found to be acceptable.Based upon the investigations results a capa is not necessary.
Event or Problem Description
Update: additional information received.Patient harm changed from surgery delay to addtional medical intervention.

• Brand Name: ENNOVATE POLYAX.SCREW 7.5X50MM CANULATED
• Common Device Name: IMPLANTS POSTERIOR STABILISATI
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12150049
• Report Number: 9610612-2021-00499
• Device Sequence Number: 17308501
• Product Code: NKB
• UDI-Device Identifier: 04046964987441
• UDI-Public: 4046964987441
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K180433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2021

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: SY645TS
• Device Catalogue Number: SY645TS
• Device Lot Number: 52646568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2021
• Supplement Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 07/12/2021
• Supplement Report FDA Received Date: 08/20/2021
• 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