MAUDE Adverse Event Report: ZIMMER GMBH ANATOMICAL SHOULDER TRIAL HUMERAL PE-INSERT, 40-3; ANATOMICAL SHOULDER, TRIAL HUMERAL

Model Number N/A

Device Problem Material Fragmentation (1261)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The manufacturer did not receive the device for investigation, but it was mentioned that it will be returned.The manufacturer did not receive other source documents for review.As no lot number was provided, the device history records could not be reviewed.Additional information has been requested and is currently not available.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.(b)(4).

Event Description

It was reported that an anatomical shoulder trial humeral pe-insert, 40-3 was found damaged (polyethylene particles came off) during instrument inspection.No patient was harmed.

Manufacturer Narrative

Device history records (dhr): ref: 01.04239.740 lot: 05.180546 a concession was found.Reason: out of dimension.The product is on the market since 2005, thus the minimal deviation in the size of the instrument does not affect its functionality.The device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trend considering the following event was identified: insert damaged / broken.A trend is identified if at least one of the following criteria is met: 3 similar events within 1 month for the same item number 6 similar events within 6 months for the same item number 2 similar events for the same lot number review of event description: it was reported that the products were tested on the instrument table and the parts were found damaged.Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents were received.Devices analysis: three trial inserts were received for investigation.The three inserts show damages in form of nicks and scratches.Additionally, the dents on the posterior side of the inserts are partially missing.It has also to be noted that one instrument was manufactured in 2005, another in 2006 and the third in 2016.This means that two of the instruments were on the market since more than 10 years.Review of product documentation: ifu d011500192 manual orthopedic surgical instruments 97-5000-170-00 states that "misuse reduces useful life and/or increases injury risk.Repeated processing according to these instructions has minimal effect on zimmer¿s reusable manual instruments.End of life is normally determined by wear and damage due to use." in the chapter "instrument/provisional use and care".Additionally, under "inspection and functional testing" it is stated that "if damage or wear is noted that may compromise the function of the instrument, do not use the device and contact your zimmer representative for replacement." root cause analysis root cause determination using rmw: instrument breaks, deforms, diverge or parts remain in wound due to inadequate design for intended performance => not possible -> a systematic issue with design and/or material properties would have been detected as part of the issue evaluation assessment.Instrument breaks, deforms, diverge or parts remain in wound due to mechanical properties of material insufficient => not possible -> a systematic issue with design and/or material properties would have been detected as part of the issue evaluation assessment.Wear particles can get into the wound can cause foreign body reaction due to excessive wear particles generated by instrument interfaces during use => possible, the received instruments shows scratches and damage probably form instruments.Instrument breaks, deforms, diverge or parts remain in wound due to surgeon or staff unfamiliar with instrument usage and handling => possible, it is unknown if the surgeon and/or op staff are unfamiliar with the trial inserts.Thus it cannot be excluded.However, ifu d011500192 (section: precautions), ifu d011500192 (section: instructions) and manual orthopedic surgical instruments 97-5000-170-00 (section: instructions) together with the surgical technique of implants contain all information about the handling of the trial inserts.Damaged instruments, implants, body or wrong operational step due to surgeon or staff unfamiliar with instrument usage and handling => possible, it is unknown if the surgeon and/or op staff are unfamiliar with the trial inserts.Thus it cannot be excluded.However, ifu d011500192 (section: precautions), ifu d011500192 (section: instructions) and manual orthopedic surgical instruments 97-5000-170-00 (section: instructions) together with the surgical technique of implants contain all information about the handling of the trial inserts.Conclusion summary: it is reported that the products were tested on the instrument table and the parts were found damaged.The three inserts received for investigation show damages in form of nicks and scratches.Additionally, the dents on the posterior side of the inserts are partially missing.It has also to be noted that one instrument was manufactured in 2005, another in 2006 and the third in 2016.This means that two of the instruments were on the market since more than 10 years and possibly reached the end of their life.The damage on the parts probably was originated by the use of surgical instruments such as tweezers.Based on the available information, the inserts were damaged during surgery and reached the end of their life due to excessive deterioration of instruments during long term use.The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).

• Brand Name: ANATOMICAL SHOULDER TRIAL HUMERAL PE-INSERT, 40-3
• Type of Device: ANATOMICAL SHOULDER, TRIAL HUMERAL
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6944198
• MDR Text Key: 90305666
• Report Number: 0009613350-2017-01434
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/07/2018

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 Model Number: N/A
• Device Catalogue Number: 01.04239.740
• Device Lot Number: 05.180546
• Other Device ID Number: 00889024287815
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2017
• Initial Date FDA Received: 10/12/2017
• Supplement Dates Manufacturer Received: 01/26/2018
• Supplement Dates FDA Received: 02/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1