MAUDE Adverse Event Report: AESCULAP AG S4 POLYAXIAL SCREW 6.0X45MM; ORTHOSIS, SPINAL PEDICLE FIXATION

Model Number	SW776T
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation results: visual investigation: the implant arrived detached in its three components.The screw itself exhibit no damages or defects, also the body.The insert shows a bent catch nose (arrowed).That the plate with the catch nose is bent.With this nose out of alignment a reliable catch of the insert in the body is no longer given.Batch history review: the device quality and manufacturing history records (dhr) have been checked for all available lot numbers and the products found to be according to our specification valid at the time of production.There are no similar complaints against the same lot number(s) with this error pattern.Conclusion and measures: on the basis of the current information and the investigation, a clear conclusion can not be drawn.There is no indication for a material defect or manufacturing failure on the baisis of the device history records.The current failure rate is within the risk analysis and therefore acceptable.Based on the investigations and results of the 8d report no capa is necessary.
Event or Problem Description
It was reported that there was an issue with s4 polyaxial screw 6.0x45mm (part # sw776t).According to the complainant, the product components separated while attempting to screw.The malfunction prolonged the surgery for 10 minutes.Additional information has been requested, but has not yet been made available.Should additional relevant information become available, a supplemental medwatch report will be submitted.The malfunction is filed under aag reference (b)(4).

• Brand Name: S4 POLYAXIAL SCREW 6.0X45MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10782157
• Report Number: 9610612-2020-00613
• Device Sequence Number: 3884087
• Product Code: MNI
• UDI-Device Identifier: 04038653401420
• UDI-Public: 4038653401420
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: K032219
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/03/2020

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 Model Number: SW776T
• Device Catalogue Number: SW776T
• Device Lot Number: 52588310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2020
• Initial Report FDA Received Date: 11/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1