MAUDE Adverse Event Report: ZIMMER GMBH ALLOFIT, IMPACTOR, CURVED; UNKNOWN

Model Number N/A

Device Problem Defective Device (2588)

Patient Problem No Information (3190)

Event Date 10/10/2017

Event Type  malfunction  

Manufacturer Narrative

The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive yet the device, however it is indicated by complainant that it will be returned for investigation.The device history records were reviewed and found to be conforming.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 on (b)(6) 2017 the connection screw of the allofit, impactor, curved was defective.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.Trend analysis: an other complaint for the lot number 16245984 has been reported.Due to different error patterns of both complaints, no trend for this lot was identified.Device history records (dhr): the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Review of event description: it was reported that the connection screw of the allofit impactor is defective.No clear event description was available.Review of received data no medical data such as surgical notes or any other case-relevant documents received.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 additional information for this case.The missing information was requested at complainant the latest one on december 5, 2017 but was not available.Devices analysis: no product was returned to zimmer biomet for in-depth analysis.According to the information received, the product location is unknown.Review of product documentation: inspection plan: characteristic no.26 feature ¿screw thread m8x1¿ with scope of testing: inspection with first lot.Means of inspection: gauge.Root cause analysis: root cause determination using rmw : instrument breaks, deforms, diverges impairing its function due to inadequate design for intended performance not possible, a systematic issue with design would have been detected as part of the issue evaluation assessment instrument breaks, deforms, diverges impairing its function due to mechanical properties of material insufficient not possible, as according to the material compatibility specification sap the material has been tested.Moreover, a systematic issue with material properties would have been detected as part of the issue evaluation assessment instrument cannot be used with the mating instrument or mating implant as intended due to failure of instrument mating condition possible, as it cannot be excluded based on the available information.Damaged instruments, implants, body or wrong operational step due to surgeon or operating room staff unfamiliar with instrument usage and handling possible, as it cannot be excluded based on the available information.Instrument breaks or deforms due to off-label / abnormal-use possible, as it cannot be excluded based on the available information.Conclusion summary the allofit impactor has not been returned for an investigation, therefore the event "connection screw defective" could not be confirmed.It was found that the instrument from this complaint has been delivered to the hospital more than one year prior to the event.It seems very unlikely, that the impactor has not been in use during this time period.Therefore a damage to the screw during use seems most likely.It might be possible that the impactor has been treated with excessive forces, which could have led to a damage of the connection screw.Another possibility might be, that the impactor has been screwed incompletely or at an angle on the allofit cup, leading to a damage to the threads of the connection screw.Based on the available information, an exact root cause could not be determined.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).

• Brand Name: ALLOFIT, IMPACTOR, CURVED
• Type of Device: UNKNOWN
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 7003790
• MDR Text Key: 92476944
• Report Number: 0009613350-2017-01527
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: PN/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: 04/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2017
• 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: 01.00469.002
• Device Lot Number: 16245984
• Other Device ID Number: 00889024280915
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1