MAUDE Adverse Event Report: SYNTHES GMBH ANTIROTATION SCREW FOR FEMORAL NECK SYS 95MM LENGTH - STERIL; APPLIANCE,FIXATION,NAIL

Catalog Number 04.168.495S

Device Problem Break (1069)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent open reduction internal fixation surgery for femoral neck fracture.The surgery was completed successfully with no surgical delay.On (b)(6), in postoperative follow-up, x-ray showed that the breakage of the antirotation-screw and telescoping of the bolt.The location where the antirotation screw was broken was the root of the threaded part at the tip of the screw follow-up will be performed at another hospital in (b)(6) 2022, and revision bha surgery may be considered at the discretion of a hip joint specialist.No further information is available.This complaint involves four (4) devices.This report is for (1) bolt for femoral neck system 95mm length-sterile this is report 1 of 2 for complaint (b)(4).

Manufacturer Narrative

Product complaint # (b)(4) complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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: 04.168.495s.Lot: l779196.Manufacturing site: (b)(4).Supplier: n/a.Release to warehouse date: 19 february 2018.Expiration date: 01 february 2028.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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 b1, b2.H6: health effect - clinical code and health effect - impact code.

Event Description

On (b)(6) 2021, the patient underwent revision surgery to remove the implants.The locking screw, plate, and bolt could be removed.The broken anti-rotation screw could be removed partially.The surgeon tried to remove the tip of the anti-rotation screw remained in the bone using a hollow reamer and an extraction pliers, but he couldn¿t.Based on the surgeon's judgment that the remained anti-rotation screw could not be removed, the remained anti-rotation screw was left as it was, and the affected area was fixed with a twin hook and ccs.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.D10: date of concomitant therapy is (b)(6) 2021.H3, h6: the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that antirotscr f/fem neck syst f/construct l had the threaded section of the screw appears to be broken, fragment is not included in the package.A dimensional inspection was unable to be performed due to post manufacturing damage.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the antirotscr f/fem neck syst f/construct l would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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.

• Brand Name: ANTIROTATION SCREW FOR FEMORAL NECK SYS 95MM LENGTH - STERIL
• Type of Device: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK GRENCHEN (CH); solothurnstrasse 186; grenchen 2540 ; SZ 2540
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12925123
• MDR Text Key: 282779452
• Report Number: 8030965-2021-09946
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 07612334089977
• UDI-Public: (01)07612334089977
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.168.495S
• Device Lot Number: L600404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: BOLT F/FEM NECK SYST F/CONSTRUCT LENGTH; LOCKSCR Ø5 SELF-TAP L40 TAN; PL 1-HO F/FEM NECK SYST TAN
• Patient Outcome(s): Required Intervention
• Patient Age: 23 YR
• Patient Sex: Female