MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ2 HI OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number	1570-11-080
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: the product was not returned to depuy synthes for evaluation.Depuy orthopedics jte: warsaw team conducted a photo investigation of the device and confirmed a hair was identified under the shrink wrap.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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 information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Received summit stem with what appears to be a hair sealed between the box and the cellophane wrap.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = the product was not returned to depuy synthes for evaluation.Depuy orthopedics jte: warsaw team conducted a photo investigation of the device and confirmed a hair was identified under the shrink wrap.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Received summit stem with what appears to be a hair sealed between the box and the cellophane wrap.Photo investigation and investigation of their packaging process was performed on [157011080 / summit por taper sz2 hi off / jr6072].Investigation of the shrink wrap area identified that the area is open and the operators do not wear hair nets while performing the shrink wrap operation.A dimensional inspection is not applicable to the reported event.The overall complaint was confirmed for the [157011080 / summit por taper sz2 hi off / jr6072].The root cause of the complaint condition can be confirmed due to the manufacturing issue.A review of the returned photograph associated with this complaint confirmed there was a small piece of hair inside the shrink wrap, the assigned operator did not perform 100% inspection for batch # jr6072 per (b)(4), rev bc at operation 140, to verify there was no foreign material under the shrink wrap.Based on the investigation findings, the root cause can be attributed to manufacturing.This quality issue was addressed through depuy synthes quality system.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Drawing/specifications reviewed? n/a.The following drawing/documents were reviewed: n/a.Device history lot =a manufacturing record evaluation was performed for the finished device lot number jr6072, and no previous non-conformances or manufacturing irregularities were identified in the depuy synthes quality system.Device history batch = null.Device history review = null upon further review, it has been determined that there is no allegation against the device, no reportable event.Further updates will only be provided if additional information is received that changes the regulatory determination.

• Brand Name: SUMMIT POR TAPER SZ2 HI OFF
• Common Device Name: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15518813
• Report Number: 1818910-2022-19220
• Device Sequence Number: 2533289
• Product Code: LPH
• UDI-Device Identifier: 10603295060031
• UDI-Public: 10603295060031
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• 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
• Report Date (Section B): 09/30/2022

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: 1570-11-080
• Device Catalogue Number: 157011080
• Device Lot Number: JR6072
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2022
• Supplement Date Received by Manufacturer: 10/11/2022
• Initial Report FDA Received Date: 09/30/2022
• Supplement Report FDA Received Date: 10/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown