MAUDE Adverse Event Report: SYNTHES GMBH 3.5MM TI LOCKING SCR SLF-TPNG W/STARDRIVE RECESS/30MM-STER; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 412.111S

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: ktt.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 history lot part: 412.111s, lot: 6l27226, manufacturing site: (b)(4), release to warehouse date: october 11, 2019, expiry date: october 01, 2029.A manufacturing record evaluation was performed for the finished device part: 412.111s, lot: 6l27226, and no non-conformances related to malfunction were identified.The nonconformance referred within the dhr is a planned one, that was aimed to monitor specific activities to manage all work orders (wo)) which were in wip in (b)(4) site, during the cutover phase for the transition from old erp (sap p01) to the new erp (sap p02).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/30mm-ster.This report is 2 of 11 for (b)(4).

• Brand Name: 3.5MM TI LOCKING SCR SLF-TPNG W/STARDRIVE RECESS/30MM-STER
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK GRENCHEN (CH); solothurnstrasse 186; grenchen 2540 ; SZ 2540
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12119195
• MDR Text Key: 269731762
• Report Number: 8030965-2021-05518
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K103002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 412.111S
• Device Lot Number: 6L27226
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention