MAUDE Adverse Event Report: SYNTHES GMBH LARGE EX-FIX OPEN ADJ CLAMP MR-CONDITIONA; APPLIANCE, FIXATION, NAIL/BLADE/PLATE

Catalog Number	390.008
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional code ktt.Complainant part is not expected to be returned for manufacturer review/investigation.Occupation: initial reporter is j&j company representative.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 history: part # 390.008, lot # 6148295, release to warehouse date: 19 may 2009, manufacturing location: (b)(4), no ncr's were generated during production.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 (b)(6) as follows: it was determined on an unknown date five (5) ex-fix clamps were unable to connect.It was stated the rod does not fit well.Patient and surgical involvement is unknown.No serious injury reported.This is report 5 of 5 for (b)(4).This report is for a large ex-fix clamp.

• Brand Name: LARGE EX-FIX OPEN ADJ CLAMP MR-CONDITIONA
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14083431
• Report Number: 8030965-2022-02356
• Device Sequence Number: 20155850
• Product Code: LXT
• UDI-Device Identifier: 07611819760592
• UDI-Public: (01)07611819760592
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• 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 Catalogue Number: 390.008
• Device Lot Number: 6148295
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2022
• Initial Report FDA Received Date: 04/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2009
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CLAMP CAN BE MOUNTED SELF-HOLD.; CLAMP CAN BE MOUNTED SELF-HOLD.; CLAMP CAN BE MOUNTED SELF-HOLD.; CLAMP CAN BE MOUNTED SELF-HOLD.; UNKNOWN RODS.
• Patient Sex: Unknown