MAUDE Adverse Event Report: DEPUY SPINE INC PIPELINE LS DILATOR HOLDER; MISC ORTHO SURGICAL INSTR

Model Number	287105015
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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.Reporter is a company representative.The device was 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 during routine incoming inspection of a loaner set on an unknown date, it was observed that a pipeline ls dilator holder was broken.There was no patient involvement.This report is for a pipeline ls dilator holder.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Product complaint (b)(4).Udi: (b)(4).H4, h6: additional information.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.The portion of the nylon coating has broken off one of the jaws of the dilator.The handle also appears minorly bent inward.The received condition was consistent with the complaint condition thus the complaint was confirmed.After tightening the dilator, the device does not loosen easily.Significant force must be applied to separate the ratcheting jaws due to the mild inward deformity identified.The device is also functionally jammed.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.The overall complaint was confirmed for the received the pipeline ls dilator holder as the nylon coating has broken off, a deformity in the handle was identified and the device was functionally jammed.Although no definitive root-cause can be determined it¿s possible the device experienced unintended forces.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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.

• Brand Name: PIPELINE LS DILATOR HOLDER
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9547876
• Report Number: 1526439-2020-00159
• Device Sequence Number: 2314495
• Product Code: LXH
• UDI-Device Identifier: 10705034217604
• UDI-Public: (01)10705034217604
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2019

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: 287105015
• Device Catalogue Number: 287105015
• Device Lot Number: KW1745329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Initial Date Received by Manufacturer: 12/09/2019
• Supplement Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 01/03/2020
• Supplement Report FDA Received Date: 01/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1