MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 2.0MM 22-13-5 SS CABLE/SLV SET; BONE FIXATION CERCLAGE

Catalog Number	3704-0-510
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Event relates to a packaging issue.
Event or Problem Description
Dr.From the hospital reported following event: "at the opening" damaged double packaging: sterility not guaranteed, material not given to surgery.Use of another product with the same reference.
Additional Manufacturer Narrative
Lot code corrected.An event regarding a packaging issue involving a dall miles cable was reported.The event was confirmed through visual analysis of the packaging.Method & results: -device evaluation and results: visual inspection: visual inspection was completed by the senior manufacturing engineer in the packaging department which indicated the following: substantial damage and tearing of the carton.A pen/ marker line on the folded tab on the carton.A corresponding pen/ marker line on the tear of the pouch.Dimensional inspection not performed as the complaint does not relate to device dimensions.Functional inspection: not performed as the failure mode could not be replicated.Material analysis: not performed as the complaint does not relate to material integrity.-medical records received and evaluation: no medical records were received for review with a clinical consultant -device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the reported lot.Conclusion: the investigation concluded that the damage to the blister occurred after the packaging step as there are sufficient inspection steps in the packaging process to ensure that the product is shipped without any damage to the carton, shrink-wrap or product labels.It is probable that the damage occurred post manufacturing, in shipment or transit to the hospital or during an attempt to open the product.It was further noted that this complaint is not manufacturing related.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Dr.From the hospital reported following event : " at the opening "damaged double packaging: sterility not guaranteed, material not given to surgery.Use of another product with the same reference.

• Brand Name: 2.0MM 22-13-5 SS CABLE/SLV SET
• Common Device Name: BONE FIXATION CERCLAGE
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8325595
• Report Number: 0002249697-2019-00900
• Device Sequence Number: 11251395
• Product Code: JDQ
• UDI-Device Identifier: 07613327036374
• UDI-Public: 07613327036374
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K971741
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2019

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 Expiration Date: 07/31/2023
• Device Catalogue Number: 3704-0-510
• Device Lot Number: 66628703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2019
• Initial Date Received by Manufacturer: 01/15/2019
• Supplement Date Received by Manufacturer: 03/26/2019
• Initial Report FDA Received Date: 02/11/2019
• Supplement Report FDA Received Date: 04/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other