MAUDE Adverse Event Report: ZIMMER GMBH SCREW FOR 75.11.00-05

Model Number N/A

Device Problems Fracture (1260); Device Handling Problem (3265)

Patient Problem No Information (3190)

Event Date 07/14/2017

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive the device for investigation.As no lot number was provided, the device history records could not be reviewed.The manufacturer did not receive x-rays, or other source documents for review.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.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

It was reported that during the surgery the locking screw for the alignment guide snapped in half.Half dropped into the patients hip wound what was not noticed.Consultant reviewed x-ray and decided to leave the piece in the patient.Notes: the implantation and explantation dates are left empty as the device involved in this complaint is an instrument.Hence, no expiration date is captured, for the same reason.

Manufacturer Narrative

Investigation results were made available.As for zimmer specialists to perform an in-depth analysis it is required to have all necessary information at hand, it was therefore tried several times to receive more information for this case.The missing information (lot number, surgical reports, all available x-rays and pictures, patient's data) was requested the latest one on (b)(6), 2017 but was not available.A technical investigation was not possible to be performed, as the device was not at hand for investigation.Trend analysis: no trend considering the following event was identified: screw fractured.Device history records (dhr): as no lot numbers were provided for the devices, the device history records could not be reviewed.At zimmer (b)(4) all medical devices prior release to market undergo several quality inspections as defined in our quality procedures.Our quality inspection- and deviation procedures ensure that only products fulfilling the specification are sold.These procedures are part of the overall quality management system at zimmer (b)(4) and get regularly audited by our notified body, competent authorities and internal and external auditors.Thus, for all products sold to the market can be assumed having a complete and correct dhr.Review of event description: it was reported that the locking screw for the alignment guide snapped in half.Half dropped into the patients hip wound and half was recovered.The half retained by the patient was not noticed until the patient had returned to the ward.X ray taken to establish retention of proximal part of screw in patient.Consultant reviewed x-ray and decided to leave the screw in situ.Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents were received.Devices analysis: no product was returned to zimmer biomet for in-depth analysis (one broken half was left in patient, the other half was discarded).Review of product documentation: - compatibility check: the screw with ref# 75.11.01-05 reported in this case is not to be used with the mentioned lateral alignment guide with ref# (b)(4) (reported under zimmer inc., warsaw (b)(4)).The locking screw reported in the compliant should be used with flexible drill drivers with ref# 00-8790-007-05 and ref# 75.11.00-05.- biocompatibility specification: in accordance with iso 10993-1, the hip instruments group 1: cutting and drilling instruments are categorized as ¿external communicating devices¿ with "tissue/bone" contact for less than 24 hours (a ¿ limited).Patient needs to be monitored.Root cause analysis: root cause determination using rmw: - fracture of instrument due to general corrosion (crevice, pitting, galvanic) => possible, no product is returned and therefore corrosion cannot be excluded.- 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.- instrument breaks or deforms due to off-label / abnormal-use => possible, the screw (75.11.01-05) is not to be used with the lateral alignment guide (00-7807-015-02).The locking screw reported in the compliant is to be used with flexible drill drivers 00-8790-007-05 and 75.11.00-05.It is possible that the screw was used off-label or that the reported reference number of the screw is wrong.Conclusion summary: it is reported that the locking screw for the alignment guide snapped in half and half remained in the patient wound.Consultant reviewed x-ray and decided to leave the screw in situ.Biocompatibility of the instrument is ensured for 24 hours as the instruments are categorized as ¿external communicating devices¿ with "tissue/bone" contact for less than 24 hours.Patient needs to be monitored.The cause of screw fracture cannot be determined based on the information at hand.Additionally, as no devices or photos of the instrument were received the condition of the components is unknown.The screw (75.11.01-05) is not to be used with the lateral alignment guide (00-7807-015-02) reported in the complaint.It is possible that the screw was used off-label or that the reported reference number of the screw is wrong.According to the available information, the screw was used off-label.The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed.Zimmer's reference number of this file is (b)(4).

• Brand Name: SCREW FOR 75.11.00-05
• 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: 6819686
• MDR Text Key: 83606970
• Report Number: 0009613350-2017-01101
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PNA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 75.11.01-05
• Device Lot Number: UNKNOWN
• Other Device ID Number: 00889024302754
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/26/2017
• Initial Date FDA Received: 08/25/2017
• Supplement Dates Manufacturer Received: 11/30/2017
• Supplement Dates FDA Received: 12/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other