MAUDE Adverse Event Report: ZIMMER GMBH MPJ TI-PLATE, 5-HOLE, SYS2.7, S, 28MM; NORMED TITANIUM OSTEOTOMY PLATING SYSTEM

Model Number N/A

Device Problem Component or Accessory Incompatibility (2897)

Patient Problem No Information (3190)

Event Date 11/18/2016

Event Type  malfunction  

Manufacturer Narrative

The manufacturer did not receive devices for review.As no lot numbers were provided for the devices, the device history records could not be reviewed.A cause for this specific event cannot be ascertained from the information provided.Should additional information become available and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.(b)(4).

Event Description

It was reported that in a surgery on (b)(6) 2016 unknown angular stable screw normed trauma could be screwed intraoperatively through the screw holes of an mpj ti-plate, 5-hole, sys2.7, s, 28mm without locking angularly stable.The plates had to be removed intraoperatively and be exchanged by other systems.The surgery was delayed for an unknown period of time.Additional information has been requested and is currently not available.No information about patient's outcome has been received so far.At this point of time we don't have information if a serious injury occurred in this case.

Manufacturer Narrative

Trend analysis: no trend identified: device history records (dhr): the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Event summary: it is reported that during several surgeries normed 2,7 angular stable screws intraoperatively slipped through the screw holes of metatarsophalangeal joint (mpj) and pedofix plates.The plates had to be removed intraoperatively and replaced with other systems.In total 7 complaints were opened: (b)(4).Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents received - for six of the complaints the event reported is slipping of the 2.7 mm screws through the mpj plate: (b)(4).In (b)(4) the event reported is slipping of the 2.7 mm screws through a pedofix plate.Devices analysis: only for two complaints the products were returned for investigation.The investigation can be summarized as follows.Visual examination: - (b)(4): a mpj plate ref: 28.05.013, lot: 16856 and three screws were returned.- (b)(4): a mpj plate ref: 28.05.013, lot: 16856 and two screws were returned.The returned products were visually examined and found to be scratched and partially deformed.Measurements: as the returned products were found to be partially damaged, a reliable measurement of the relevant characteristics and the comparison with the specification is not possible.Functional test: a functional test was performed and the screws were found to slip through the screw holes.The functional test confirms the event reported.Comparison of the complained devices with unused devices: screws from 8 different lots and a mpj plate were requested from the central warehouse.These unused screws were compared with the screws involved in the complaints.The visual examination evidenced that the screws returned in the complaints and the one retrieved from the central warehouse show different characteristics.The main difference are found on the screw head, in the complained screws the thread is continuous until the end of the screw head, while in the screws from the warehouse the thread stops before the end of the screw head and there is a thread-free ¿cap¿.The lack of the mentioned ¿cap¿ and the continuous thread on the complained screws is visible also by looking the screw from the top.The mpj plate (lot: 16856) returned from the warehouse has the same lot number as the two plates returned with the complaints.This unused plate was inspected and found to be within specification.Root cause analysis: a total of 7 complaints related to screws slipping through mpj plates and pedofix plates were received from (b)(6).The products affected in the complaints were returned only for two of the complaints.In total, two mpj plate (lot: 16856) and five screws were received for investigation.The returned products were found to be scratched and partially deformed and the functional test confirmed the slipping of the screws through the screw holes of the plate.A preliminary test with a test locking screw showed that the test screw functioned as intended and did not slip through the hole of the plate.In order to find a root cause for the issue, several screws and plates were requested from the central warehouse and compared with the received complained devices.The comparison evidenced that the screws returned in the complaints and the one retrieved from the central warehouse show different characteristics.The main differences are found on the screw head, where in the complained screws the thread is continuous until the end of the screw head and lack of a thread-free ¿cap¿.In the screws from the warehouse the thread stops before the end of the screw head and there is a thread-free ¿cap¿, which allows the locking of the screw in the screw hole.Due to this major difference, it can be stated that the screws that caused the complaints were not manufactured by zimmer (b)(4) and were not intended to be used as locking screws with the mpj and pedofix plates.The plates were found to be according specification and therefore did not contribute to the issue.Based on the given information and the results of the investigation, we could identify a root cause for this issue.The complained screws are not 2.7 mm locking screws manufactured by zimmer (b)(4) and are not intended to be used as locking screws with the mpj and pedofix plates.However, the manufacturer of the screws and the contributing factors leading to the reported complaints remain unknown.The need for further corrective measures is not indicated and zimmer (b)(4) considers this case as closed.Zimmer reference number of this file is (b)(4).

• Brand Name: MPJ TI-PLATE, 5-HOLE, SYS2.7, S, 28MM
• Type of Device: NORMED TITANIUM OSTEOTOMY PLATING SYSTEM
• 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: kevin escapule ; 1800 west center street; warsaw, IN 46580 ; 8006136131
• MDR Report Key: 6173297
• MDR Text Key: 62384848
• Report Number: 0009613350-2016-01433
• Device Sequence Number: 1
• Product Code: HRS
• 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: 11/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2016
• 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: 28.05.013
• Device Lot Number: 16856
• Other Device ID Number: 00889024107106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1