MAUDE Adverse Event Report: SYNTHES GMBH LOCKSCR Ø5 SELF-TAP L38 TAN; ORTHOPAEDIC BONE SCREW, NON-BIOABSORBABLE, NON-STERILE

Catalog Number 412.213S

Device Problems Device-Device Incompatibility (2919); Material Twisted/Bent (2981)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/22/2022

Event Type  Injury  

Event Description

Device report from depuy synthes reports an event in japan as follows: this is report 1 of 2 for (b)(4).It was reported that on (b)(6) 2021, the patient underwent the surgery for femoral neck fracture with the fns implants in question.According to the report, the surgery was completed successfully without any surgical delay.After the surgery, femur head osteonecrosis was confirmed on an unknown date.The fns implants were removed and replaced with artificial bone head on (b)(6) 2022.In the revision surgery, the locking screw could not be removed with dedicated screwdriver (fns -4).The locking screw head was stripped because of repeated attempts to remove the locking screw.A screw for extraction and a drill for extraction were used as per the rescue procedure surgical technique, but the locking screw did not come out.Eventually the surgeon drilled the screw head with a drill carbide and removed it.The remaining screw shaft part was removed using a halo reamer and an extraction bolt.Some metal fragments were scattered in the body when a drill carbide was used, but they were thoroughly washed and removed as much as possible, and the surgeon judged that there was no problem.The surgery was completed successfully with 1 hour delay.No further information is available.This complaint involves two (2) devices.

Manufacturer Narrative

Additional narrative: device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device history lot: part # 412.213s.Lot # 7l88357.Manufacturing site: (b)(4).Release to warehouse date: 18 feb2021, expiration date: 01 feb2031, supplier: (b)(4).A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Non-sterile part # 412.213.Non-sterile lot # 89p2605.Manufacturing site: (b)(4).Release to warehouse date: 10 feb 2021.A manufacturing record evaluation was performed for the not sterile lot number, and no non-conformances were identified.Device history batch: null.Device history review: null.

• Brand Name: LOCKSCR Ø5 SELF-TAP L38 TAN
• Type of Device: ORTHOPAEDIC BONE SCREW, NON-BIOABSORBABLE, NON-STERILE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14465409
• MDR Text Key: 293632060
• Report Number: 8030965-2022-03380
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K000682
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

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
• Device Operator: Health Professional
• Device Catalogue Number: 412.213S
• Device Lot Number: 7L88357
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/23/2022
• Initial Date FDA Received: 05/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention