MAUDE Adverse Event Report: SYNTHES GMBH LOCKSCR Ø5 SELF-TAP L28 TAN; ORTHOPAEDIC BONE SCREW, NON-BIOABSORBABLE, NON-STERILE

Catalog Number 413.328S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Necrosis (1971)

Event Type  Injury  

Event Description

Device report from depuy synthes reports an event in japan as follows: this is report 4 of 6 for (b)(4).It was reported by the sales rep in japan that on (b)(6) 2021, the patient underwent the open reduction internal fixation with the dhs for the fracture of the right femoral neck.The surgery was completed successfully without any surgical delay.On (b)(6) 2022, the postoperative x-rays showed that crushing of the femoral head and protrusion of the 6.5 ccs into the hip joint.On (b)(6) 2022, this event was found during a meeting with another physician than the one in charge of the case.The sales rep has not been able to meet with the surgeon.According to another physician, it seemed to be osteonecrosis of the femoral head.There was no clear description in the medical record regarding osteonecrosis of the femoral head.The revision surgery with removal of the implants and the bipolar hip arthroplasty was schedule to be performed on (b)(6) 2022.No further information is available.This complaint involves six(6) 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.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or 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.

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.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 review: a manufacturing record evaluation was performed for part: 413.328s, lot: 9234835; and no non-conformances were identified.

• Brand Name: LOCKSCR Ø5 SELF-TAP L28 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 BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14757342
• MDR Text Key: 294936123
• Report Number: 8030965-2022-04196
• 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: Other Health Care Professional
• Type of Report: Initial,Followup

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 413.328S
• Device Lot Number: 9234835
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/25/2022
• Initial Date FDA Received: 06/21/2022
• Supplement Dates Manufacturer Received: 06/30/2022
• Supplement Dates FDA Received: 07/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2014
• 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
• Patient Sex: Female