MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5 THRD CERCLAGE POSITIONING PIN-SILE; CERCLAGE, FIXATION

Model Number	298.803S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales 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 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 (b)(6) 2019, patient was revised due to infection.Concomitant device reported: altrx neut 36idx58od(122136058/j2653a).Apex hole elim (124603000/d18101698).Pinn cup 58mm (121722058/j21n76).Bone screw 6.5mmx45mm (121745500/d18051131).This report is for one (1)4.5 thrd cerclage positioning pin-sile.This is report 8 of 20 for complaint (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h6 part # 298.803s, synthes lot # h326726, supplier lot # n/a, release to warehouse date: april 04, 2017, manufactured by: synthes monument, no ncrs were generated during production.Device history review : review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Product was not returned.Based on the information available, it has been determined that no corrective and 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.E1, e2, e4, g2.

• Brand Name: 4.5 THRD CERCLAGE POSITIONING PIN-SILE
• Common Device Name: CERCLAGE, FIXATION
• 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
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15677047
• Report Number: 2939274-2022-03428
• Device Sequence Number: 15058140
• Product Code: JDQ
• UDI-Device Identifier: 10886982182531
• UDI-Public: (01)10886982182531
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K992891
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 298.803S
• Device Catalogue Number: 298.803S
• Device Lot Number: H326726
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2022
• Supplement Date Received by Manufacturer: 10/18/2022
• Initial Report FDA Received Date: 10/26/2022
• Supplement Report FDA Received Date: 11/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALTRX NEUT 36IDX58OD; APEX HOLE ELIM POSITIVE STOP; CANN-LOCKSCR Ø7.3 L35 SST; CERCL-CABLE W/CRIMP Ø1 SST; CERCL-CABLE W/CRIMP Ø1 SST; CERCL-CABLE W/CRIMP Ø1 SST; CERCL-CABLE W/CRIMP Ø1.7 SST; CERCL-CABLE W/CRIMP Ø1.7 SST; CERCL-CABLE W/CRIMP Ø1.7 SST; CERCL-CABLE W/CRIMP Ø1.7 SST; CERCL-CABLE W/CRIMP Ø1.7 SST; CERCL-CABLE W/CRIMP Ø1.7 SST; LCP PROXFEM HOOKPL 4.5/5 SHAFT 12HO L313; LCP PROXFEM HOOKPL 4.5/5 SHAFT 8HO L241; LOCKSCR Ø5 SELF-TAP L40 SST; PINN CAN BONE SCREW 6.5MMX45MM; PINNACLE SECTOR II CUP 58MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male