MAUDE Adverse Event Report: SYNTHES GMBH BOLT FOR FEMORAL NECK SYS 80 LENGTH-SILE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number 04.168.280S

Device Problem Migration (4003)

Patient Problems Failure of Implant (1924); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/06/2022

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2022 the revision of femoral neck system due to cut through.The surgery was completed without a surgical delay.Some fragments was generated.Patient status/ outcome: unknown this report is for one (1)bolt for femoral neck sys 80 length-sile.This is report 2 of 4 for complaint (b)(4).

Manufacturer Narrative

Additional narrative: device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter occupation: reporter is a j&j sales representative.(b)(4).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.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.

• Brand Name: BOLT FOR FEMORAL NECK SYS 80 LENGTH-SILE
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK GRENCHEN (CH); solothurnstrasse 186; grenchen CO 2540 ; SZ 2540
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15491671
• MDR Text Key: 300647029
• Report Number: 8030965-2022-07397
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 10886982274724
• UDI-Public: (01)10886982274724
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172872
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,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?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.168.280S
• Device Catalogue Number: 04.168.280S
• Device Lot Number: 395P909
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/06/2022
• Initial Date FDA Received: 09/27/2022
• Supplement Dates Manufacturer Received: 10/04/2022
• Supplement Dates FDA Received: 10/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 5.0 TI LCKNG SCR SLF-TPNG T25 SD 36-SILE; ANTIROTATION SCR FEM NECK 85 LNTH -S; FEMORAL NECK SYSTEM PL 1 HOLE - STERILE
• Patient Outcome(s): Required Intervention
• Patient Age: 88 YR
• Patient Sex: Female