MAUDE Adverse Event Report: SYNTHES GMBH 3.5MM TI LOCKING SCR SLF-TPNG W/STARDRIVE RECESS/36MM-STER; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 412.115S

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional product code: (b)(4).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 at the time of filing this report.The 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 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 (b)(6) 2021, the patient underwent for an open reduction internal fixation surgery for fracture of distal end of left tibia.The surgery was completed successfully without any surgical delay.Since the implants in question are still in the patient's body, no investigation on the implants is required.No further information is available.This complaint involves eleven (11) devices.This report is for (1) 3.5mm ti locking scr slf-tpng w/stardrive recess/36mm-ster this report is 7 of 11 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.H4, h6: part: 412.115s, lot: 34p6357, manufacturing site: grenchen, release to warehouse date: 17 january 2020, expiry date: 01 january 2030.A manufacturing record evaluation was performed for the finished device lot and no non-conformances were identified.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 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: 3.5MM TI LOCKING SCR SLF-TPNG W/STARDRIVE RECESS/36MM-STER
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12119199
• MDR Text Key: 267522884
• Report Number: 8030965-2021-05524
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819152120
• UDI-Public: (01)07611819152120
• Combination Product (y/n): N
• PMA/PMN Number: K103002
• 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: 06/11/2021

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: 412.115S
• Device Lot Number: 34P6357
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/11/2021
• Initial Date FDA Received: 07/05/2021
• Supplement Dates Manufacturer Received: 07/13/2021
• Supplement Dates FDA Received: 08/10/2021
• Patient Sequence Number: 1
• Treatment: LCP DIST-TIBPL3.5 ANTERO-LAT LE 9HO L132; LOCKSCR Ø3.5 SELF-TAP L30 TAN; LOCKSCR Ø3.5 SELF-TAP L32 TAN; LOCKSCR Ø3.5 SELF-TAP L34 TAN; LOCKSCR Ø3.5 SELF-TAP L34 TAN; LOCKSCR Ø3.5 SELF-TAP L38 TAN; LOCKSCR Ø3.5 SELF-TAP L40 TAN; LOCKSCR Ø3.5 SELF-TAP L44 TAN; LOCKSCR Ø3.5 SELF-TAP L46 TAN; LOCKSCR Ø3.5 SELF-TAP L46 TAN
• Patient Outcome(s): Required Intervention