MAUDE Adverse Event Report: SYNTHES MONUMENT 2.5MM REAMING ROD W/BALL TIP 650MM-STERILE; REAMER

Catalog Number 351.709S

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/26/2016

Event Type  malfunction  

Manufacturer Narrative

This device was used for treatment, not diagnosis.(b)(4).Device is an instrument and is not implanted/explanted.(b)(6).The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Part #: 351.709s, lot#: h080083 (sterile) - 2.5mm reaming rod with ball tip/650mm-sterile.Quantity (b)(4).No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Sterility documentation was reviewed and determined to be conforming.Investigation summary shows, the devices were received with the clear mylar web of the sterile packaging delaminating (fused layers separated).The reaming rods were undamaged.An investigation by the supplier confirmed the issue and found a deviation with the pouch's material supplier.The investigation is confirmed and further investigation is being documented under ((b)(6)'s internal non-conformance system).The preliminary investigation by the pouch manufacturer and tier 2 material supplier, the issue is believed to affect a limited number of pouches which were manufactured using a specific raw material lot from tier 2 supplier (b)(6).A quality event occurred during the manufacture of this lot of raw material and this has been confirmed by (b)(6).(b)(6) has procedures in place to ensure culling of all affected material when a quality event occurs.However an escape is suspected of occurring during manufacture of this lot.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes (b)(4) reports an event as follows: it was reported that during a procedure, it was difficult to open the packaging for the reaming rod as it was torn and split.The reaming rod was unusable, the surgery was prolonged about 15 minutes with risk of cancellation if another reaming rod product is not available.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

A product investigation was completed: the devices were received with the clear mylar web of the sterile packaging delaminating (fused layers separated).The reaming rods were undamaged.An investigation by the supplier confirmed the issue and found a deviation with the pouch's material supplier.The investigation is confirmed.Preliminary investigation by the pouch manufacturer and tier 2 material supplier, the issue is believed to affect a limited number of pouches which were manufactured using a specific raw material lot from tier 2 supplier (b)(4).A quality event occurred during the manufacture of this lot of raw material and this has been confirmed by (b)(4).(b)(4) has procedures in place to ensure culling of all affected material when a quality event occurs.This is a confirmed manufacturing issue, and steps have been taken to address it.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.

• Brand Name: 2.5MM REAMING ROD W/BALL TIP 650MM-STERILE
• Type of Device: REAMER
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5999992
• MDR Text Key: 56540268
• Report Number: 1719045-2016-10736
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/26/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2021
• Device Catalogue Number: 351.709S
• Device Lot Number: H080083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/03/2016
• Initial Date FDA Received: 10/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1