MAUDE Adverse Event Report: ZIMMER GMBH ALLOFIT ALLO-C SCR PLUG STER N/A

Model Number N/A

Device Problem Component Missing (2306)

Patient Problem No Information (3190)

Event Date 11/07/2018

Event Type  malfunction  

Manufacturer Narrative

The manufacturer did not receive the device yet, however it is indicated by complainant that it will be returned for investigation. The manufacturer did not receive x-rays, or other source documents for review. The device history records were reviewed and found to be conforming. 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 during surgery it was noticed that the packaging "plugs for screw holes" just contained one plug instead of 7 as intended and stated. There should be seven in the packaging. To complete the procedure another product was opened.

Event Description

No event update.

Manufacturer Narrative

Device history records (dhr): the device manufacturing quality records indicate that the released components met all requirements to perform as intended. Trend analysis: a trend considering the following event was identified: missing components in packaging however, no potential relation of the investigated event could be identified to any deviations or ncr's nor could any potential relation of the investigated event be identified to a product characteristic which was inspected by a less than 100% scope. Further investigation has been initiated. Review of event description: it was reported that there was only 1 plug contained in the packaging for plugs for screw holes instead of the required 7 plugs. This event occurred during an initial surgery for the patient. The single plug was implanted with other plugs taken from another packaging of ref. 01. 00004. 001. Review of received data: no other case-relevant documents were received. Devices analysis: only the outer pouch (avp) was returned for investigation as the plug was implanted. On the label it is indicated that qty. 7 should be in this packaging. No further statements can be given. Review of product documentation reviewing the dhr 2955750 shows that the packaging of one sku with item# 01. 00004. 001 has a quantity of 7 pieces. According to the sme of the finish department a manufacturing/planning issue is assumed (wrong bill of material). It was reported that there was only 1 plug contained in the packaging for plugs for screw holes instead of the required 7 plugs. This event occurred during an initial surgery for the patient. The single plug was implanted with other plugs taken from another packaging of ref. 01. 00004. 001. Based on the returned product and the given information the complaint could be confirmed. Only the outer pouch (avp) was returned for investigation as the plug was implanted. On the label it is indicated that qty. 7 should be in this packaging. Reviewing the dhr 2955750 confirms that the packaging of a sku with item# 01. 00004. 001 has a quantity of 7 pieces. The most likely root cause for this discrepancy is a manufacturing/planning issue (wrong bill of material). Based on the available information further investigation has been initiated to determine the necessity of potential corrective and/or preventive actions. The field action fa 2018-07 (zfa 2018-00632) has been initiated. A product removal has been conducted (usa not affected). Zimmer biomet's reference number of this file is (b)(4).

• Brand Name: ALLOFIT ALLO-C SCR PLUG STER
• Type of Device: N/A
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8140827
• Report Number: 0009613350-2018-01186
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 07/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 01.00004.001
• Device Lot Number: 2955750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2018
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 01/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A