MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC REDUCTION FORCEPS POINTS RATCHET 200

Model Number	399.98
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: this complaint was confirmed but the reported condition for broken couldn't be confirmed.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot: part number: 399.98 lot number: t934799 manufacturing site: (b)(6).Release to warehouse date: 29-apr-2009 a review of the device history records was performed for the finished device lot number, 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
It was reported that on an unknown date, the four (4) lid monobloc flexible reamer cases and a cannulated screw instrument and implant set graphic case are caused bioburden due to damaged casing.It was unknown when the issue was discovered.There was no patient involvement.This report is for one (1) reduction forceps points ratchet 200 this is report 1 of 1 for (b)(4).
Event or Problem Description
It was reported that on an unknown date, the four (4) lid monobloc flexible reamer cases and a cannulated screw instrument and implant set graphic case are caused bioburden due to damaged casing.It was unknown when the issue was discovered.There was no patient involvement.This report is for one (1) reduction forceps points ratchet 200 this is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: this complaint was confirmed but the reported condition for broken couldn't be confirmed.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot: part number: 399.98 lot number: t934799 manufacturing site: (b)(4).Release to warehouse date: 29-apr-2009 a review of the device history records was performed for the finished device lot number, 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.

• Brand Name: REDUCTION FORCEPS POINTS RATCHET 200
• Common Device Name: FORCEPS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• 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: 13481298
• Report Number: 2939274-2022-00391
• Device Sequence Number: 17480040
• Product Code: HTD
• UDI-Device Identifier: 10886982203168
• UDI-Public: (01)10886982203168
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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
• 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 Model Number: 399.98
• Device Catalogue Number: 399.98
• Device Lot Number: T934799
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2022
• Initial Report FDA Received Date: 02/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2009
• 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: 7.0 CANN SCR INSTR & IMPL SET GC; DD - BASE MONOBLOC FLEXIBLE REAMER CASE; DD - LID MONOBLOC FLEXIBLE REAMER CASE; REDUCTION FORCEPS POINTS RATCHET 200; SM FRAG LCP INST & IMPL SET GRAPHIC CASE
• Patient Sex: Unknown