MAUDE Adverse Event Report: SYNTHES GMBH BOLT FOR FEMORAL NECK SYSTEM 90MM LENGTH-STERILE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number 04.168.290S

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

Patient Problems Pain (1994); Limb Fracture (4518)

Event Type  Injury  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the patient experienced post-op pain due to a fracture of the subtrochanteric femur.On (b)(6) 2020, the patient underwent the osteosynthesis surgery with the fns.On approximately november 20, 2020 the patient fractured the subtrochanteric femur and felt pain.The surgeon followed up and it was determined to leave it was as it was because the patient had a callus and was walking.Concomitant devices reported: pl 1-ho f/fem neck syst tan ( part number 04.168.000s, lot 61p9870, quantity 1).Antirotscr f/fem neck syst f/construct l (part number 04.168.490s, lot 46p9817, quantity 1).Lockscr ø5 self-tap l36 tan (part number 412.212s, lot 5l90939, quantity 1).This report involves one (1) bolt for femoral neck system 90mm length-sterile.This is report 2 of 4 for (b)(4).

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.Product complaint # (b)(4).Investigation summary : complaint is confirmed as we are able to confirm complaint description, as the collapse is visible.Furthermore, the fns construct including the locking, screw show no issue or/and damage, based on the received pictures.Additionally, there is no allegation of a device malfunction reported.Furthermore, for a further examination it is necessary for us to receive the implant back.Product was not returned therefore no further investigation possible.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 (information or/and material), the investigation will be updated as applicable.Device history lot : part: 04.168.290s, lot: 34p2944 , manufacturing site: grenchen, release to warehouse date: 07 january 2020 , expiry date: 01.Dec.2029.A manufacturing record evaluation was performed for the finished device part: 04.168.290s, lot: 34p2944 , 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.

• Brand Name: BOLT FOR FEMORAL NECK SYSTEM 90MM LENGTH-STERILE
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11279397
• MDR Text Key: 230288169
• Report Number: 8030965-2021-00834
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 07612334089847
• UDI-Public: (01)07612334089847
• Combination Product (y/n): N
• PMA/PMN Number: K172872
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.168.290S
• Device Lot Number: 34P2944
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/22/2021
• Patient Sequence Number: 1
• Treatment: ANTIROTSCR F/FEM NECK SYST F/CONSTRUCT L; LOCKSCR Ø5 SELF-TAP L36 TAN; PL 1-HO F/FEM NECK SYST TAN; ANTIROTSCR F/FEM NECK SYST F/CONSTRUCT L; LOCKSCR Ø5 SELF-TAP L36 TAN; PL 1-HO F/FEM NECK SYST TAN
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Weight: 52