MAUDE Adverse Event Report: SYNTHES GMBH CONNECSCR CANN F/ETN F/SUPRAPATELLAR APP; GUIDE, SURGICAL, INSTRUMENT

Catalog Number	03.010.404
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.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 or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the threads on the cannulated connecting screw appear stripped, making it difficult to remove connect or disconnect from nail.Protection sleeves were jammed in the protection sleeve handle and are very difficult to disassemble.Concomitant devices reported: unk - nails(part# unknown, lot# unknown, qty unknown).This report is for (1) connecscr cann f/etn f/suprapatellar app.This is report 5 of 5 for complaint (b)(4).

• Brand Name: CONNECSCR CANN F/ETN F/SUPRAPATELLAR APP
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 13120328
• Report Number: 8030965-2021-10575
• Device Sequence Number: 17272593
• Product Code: FZX
• UDI-Device Identifier: 07611819501706
• UDI-Public: (01)07611819501706
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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: 03.010.404
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/03/2021
• Supplement Date Received by Manufacturer: 02/02/2022
• Initial Report FDA Received Date: 12/30/2021
• Supplement Report FDA Received Date: 02/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CONNECSCR CANN F/ETN F/SUPRAPATELLAR APP.; HAND F/PROTECT SL F/ETN F/SUPRAPATELLAR.; PROTECT SLEEVE 12 F/ETN F/SUPRAPATELLAR.; PROTECT SLEEVE 14.5 F/ETN F/SUPRAPATELLA.; UNK - NAILS.
• Patient Sex: Unknown