MAUDE Adverse Event Report: SYNTHES GMBH BOLT FOR FEMORAL NECK SYSTEM 100MM LENGTH-STERILE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	04.168.300S
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2021
Type of Reportable Event	Malfunction
Additional 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.Additional narrative: therapy date (b)(6) 2021.Reporter is a j&j employee.Non-sterile: neck fix bolt l100 tan, part: 04.168.300 (60123910), lot: 3l89269, manufacturing site: (b)(4), release to warehouse date: 05.Apr.2019.The non-sterile article is a part of the sterile sold kit below.Kit: implkit f/fem neck syst constructl.100, part: 04.168.100s, lot: 4l34633, manufacturing site: (b)(4), release to warehouse date: 23.Apr.2019, expiry date: 01.Apr.2029.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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 the neck fix bolt l100 tan had no cosmetic issues.A dimensional inspection for the neck fix bolt l100 tan was unable to be performed due to devices being stuck together.A functional test was performed, disassembling process was unsuccessful since the drill bit, neck plate, and bolt remained jammed into the protection sleeve, causing functional problems with the mechanism of the handle.The complaint condition was able to be replicated.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 neck fix bolt l100 tan 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.
Event or Problem Description
Device report from synthes reports an event in netherlands as follows: it was reported that on (b)(6) 2021, the procedure was an implantation of an fns.Drilling the locking hole for inserting the 5.0 locking screw, the drill got stuck in the protection sleeve, for the femoral neck system insertion instruments.The doctor could not move the drill in any way.The fns was taken out of the patient and an dhs was inserted.This report involves one (1) bolt for femoral neck system 100mm length-sterile.This is report 5 of 5 for (b)(4).

• Brand Name: BOLT FOR FEMORAL NECK SYSTEM 100MM LENGTH-STERILE
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14498237
• Report Number: 8030965-2022-03489
• Device Sequence Number: 14729091
• Product Code: KTT
• UDI-Device Identifier: 10886982274762
• UDI-Public: (01)10886982274762
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K172872
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.168.300S
• Device Catalogue Number: 04.168.300
• Device Lot Number: 3L89269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DRILL BIT Ø4.3 L413; INSERT HANDLE; LOCKING GUID INSERT F/INSERTION INSTR; NECK FIX PLATE 1-HO TAN; PROTECTION SLEEVE F/INSERTION INSTR
• Patient Sex: Unknown