MAUDE Adverse Event Report: SYNTHES GMBH 1.5/1.1MM DOUBLE DRILL SLEEVE FOR 1.5MM CORTEX SCREWS/RED; GUIDE

Model Number	03.130.225
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6), 2021, while restocking and cleaning, it was noticed that the following instruments were broken.One (1) reduction forceps with the serrated jaw, ratchet, one (1)reduction forceps with points, narrow ratchet, one (1) 1.5mm/1.1mm double drill sleeve.There was no patient involvement.This complaint involves three (3) devices.This report is for (1) reduction forceps with points narrow-ratchet 132mm.This report is 2 of 3 for (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is a j&j representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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: 1.5/1.1MM DOUBLE DRILL SLEEVE FOR 1.5MM CORTEX SCREWS/RED
• Common Device Name: GUIDE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12601660
• Report Number: 8030965-2021-08531
• Device Sequence Number: 3373662
• Product Code: FZX
• UDI-Device Identifier: 10886982075406
• UDI-Public: (01)10886982075406
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/13/2021

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 Model Number: 03.130.225
• Device Catalogue Number: 03.130.225
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/13/2021
• Initial Report FDA Received Date: 10/08/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RED FORCEPS POINTS NARROW-RATCHET 132; RED FORCEPS SERRATED JAW-RATCHET 144