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 narrative: additional code: ktt.Complainant part is not expected to be returned for manufacturer review/investigation.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: 1531623, manufacturing site: (b)(4), supplier: n/a, release to warehouse date: 31 jul 2006, expiration date: n/a.A manufacturing record evaluation was performed for the finished article lot 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.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was determined on an unknown date five 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 2 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): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14083370
• Report Number: 8030965-2022-02351
• Device Sequence Number: 5190955
• Product Code: LXT
• UDI-Device Identifier: 07611819760592
• UDI-Public: (01)07611819760592
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K122455
• 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: 1531623
• 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: 07/31/2006
• 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