MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DPS HAERTOE CCI STD KIT 1.25 K-WIRE/ -S; STAPLE,FIXATION,BONE

Model Number	STANDARD
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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.Reporter is a j&j sales representative.The device has been received, the investigation is in progress, 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.
Event or Problem Description
It was reported that on (b)(6) 2022, the drill bit would not fit through plastic guide block.When trying to insert drill plastic shavings were created.Fragments generated were removed without additional intervention.Surgeon decided to use another implant.There was a surgical delay of 5 minutes.Procedure was successfully completed.There was no patient consequence.Concomitant device reported: unk - drill bits: trauma (part# unknown; lot# unknown; quantity: 1), this report is for one (1), this is report 1 of 1 for complaint.
Additional Manufacturer Narrative
Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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: investigation summary = > the product was returned to depuy synthese for evaluation.The depuy synthese team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that dps haertoe cci std kit 1.25 k-wire/ -s was observed with used condition at the holes from the plastic guide.The broken condition was not observed.A dimensional inspection was performed for the dps haertoe cci std kit 1.25 k-wire/ -s and didn't met specifications.A functional test was performed and the drill bit would not fit through plastic guide block.The complaint condition was able to be replicated due to the change order in revision drawing had a note that indicates do not mix part and only use revision b parts together and revision c parts together.The supplier used revision c pins part with revision b guides part and they do not fit together.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for the dps haertoe cci std kit 1.25 k-wire/ -s.The root cause of the complaint condition can be confirmed due to the manufacturing issue.The received condition of the dps haertoe cci std kit 1.25 k-wire/ -s confirmed that the drill bit would not fit through plastic guide block.A nonconformance record was created to further evaluate and determine the manufacturing issue in detail that led to the complaint condition.Any further corrective/preventive actions will be captured in the nonconformance record.Device history review part # 46.239.001, synthese lot # mhc220119: 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.

• Brand Name: DPS HAERTOE CCI STD KIT 1.25 K-WIRE/ -S
• Common Device Name: STAPLE,FIXATION,BONE
• 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: 15194462
• Report Number: 2939274-2022-03194
• Device Sequence Number: 12148058
• Product Code: JDR
• UDI-Device Identifier: 00810633022047
• UDI-Public: (01)00810633022047
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K191463
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,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 Model Number: STANDARD
• Device Catalogue Number: 46.239.001
• Device Lot Number: MHC220119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/14/2022
• Supplement Date Received by Manufacturer: 08/11/2022
• Initial Report FDA Received Date: 08/09/2022
• Supplement Report FDA Received Date: 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2020
• 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: UNK - DRILL BITS: TRAUMA
• Patient Sex: Unknown