MAUDE Adverse Event Report: AESCULAP AG QUINTEX SEMICONSTRAINED SCREW 4.0X14MM; IMPLANTS CERVICAL STABILISATIO

Model Number SC502T

Device Problems Mechanical Problem (1384); Device Damaged by Another Device (2915); Material Integrity Problem (2978)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/19/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Height: 170cm.If additional information is received a follow up report will be submitted.

Event Description

It was reported metal shavings detaching from the screw intraoperatively.The reporter indicated that fine metal shavings sheared off at the two screws.This happened when the screw was being inserted through the plate hole.This occurred despite central pre-graining of the screw holes.The surgery time was extended greater than 15 minutes, however the operation was completed.Additional information has been requested, however, not yet received.Associated medwatch: 9610612-2019-00259.

Manufacturer Narrative

Aesculap inc.(importer, registration no.2916714) is submitting this report on behalf of aesculap ag (manufacturer, registration no.9610612).Exemption number: e2014018 investigation: during a visual inspection we found, that the major part of the screw-thread is sheared off.The enclosed shaving is only a part of the sheared off thread.The other parts were not received.Batch history review: the manufacturing documents have been checked and found to be according to specification valid during the time of production.There are no further complains with this batch and error pattern at hand.Conclusion and root cause: the root cause for the problem is most probably usage related.Rationale: without further knowledge about the circumstances we assume, that the shaving was generated by screwing in the screw with a wrong angle, so that the thread scrapes on the edge of the place (screw hole).This is the basic cause in cases like that.A material defect or a manufacturing error can be excluded.No capa necessary.Associated medwatch: 9610612-2019-00259.

• Brand Name: QUINTEX SEMICONSTRAINED SCREW 4.0X14MM
• Type of Device: IMPLANTS CERVICAL STABILISATIO
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8525174
• MDR Text Key: 142331645
• Report Number: 9610612-2019-00258
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• PMA/PMN Number: K100243
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SC502T
• Device Catalogue Number: SC502T
• Device Lot Number: 52118739
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2019
• Distributor Facility Aware Date: 04/05/2019
• Device Age: 48 MO
• Date Manufacturer Received: 04/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR
• Patient Weight: 60