MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SYNFIX® EVOLUTION AIMING DEVICE HOLDER; IMPACTOR

Model Number 03.835.004

Device Problem Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Initial reporter is synthes sales representative.Visual inspection: the device was received at in three components: the core part cpl, the locking sleeve cpl, and the compression spring.Minor surface wear marks consistent with use were observed on the core part cpl.No abnormal marks were observed on either the locking sleeve cpl or the compression spring.These observations have no impact on the complaint condition.A small nick/gouge was observed under 10x magnification on the distal internal ledge of the locking sleeve cpl.The impact of the nick regarding functionality of the device is unknown.Functional test: the three components were able to be assembled.The core part cpl was able to traverse its full intended length, as defined by the locking tabs on the locking sleeve l.The dimensions that dictate this length are measured prior to slotting; thus, they cannot be accurately measured in the received condition.The coupling screw, coupling and aiming device were not returned, so functionality between the aiming device holder and those components was not able to be tested.The input effort required to compress the compression spring was non-linear, indicating that the device may not have been properly lubricated.The complaint device was made to the current revision of each of the above drawings/documents.No product design issues that could contribute to the complaint condition were identified.The outer sleeve inner diameter and the inner shaft outer diameter were found to be out of specification.This could potentially affect the connection between the aiming device holder and the aiming device, preventing the aiming device holder from functioning properly.Thus, the complaint condition is confirmed.Conclusion: the 03.835.004, with the lot l677300 was sent to (b)(4) for dimensional analysis and further evaluation.Below is the summary.The device is in proper condition.Some grinding traces on the outer diameter of the component shaft can be seen.This indicates normal wear and tear.No significant damage or marks on surface.The device¿s dhr was reviewed and the device underwent a series of inspections (documented in dhr) to detect any causes for the reported dysfunctionality.All functional tests were successfully passed, while, in accordance to the test results of 03.835.004 (lot l677300), no defects or any other production errors were found.Based on the above it is demonstrated the proper functionality of the investigated device, without any issues.However, the dimensional inspection took place, according to the valid inspection sheets at that time.If the instrument is connected to the counterpart via coupling, deformation of outer diameter occur if excessive force is applied during use.The hardness was measured and the results are within specification.If the instrument is connected to the counterpart via coupling, deformation of outer diameter occur if excessive force is applied during use.On both parts the hardness was measured and the results are within specification.No manufacturing related issue was identified and/or confirmed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot: part: 03.835.004, lot: l677300, manufacturing site: (b)(4), release to warehouse date: 29.Nov.2017.The device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that a loaner kit was returned on (b)(6) 2018.The sales representative had indicated the synfix evolution aiming device holder was not working properly.There was no patient involvement reported this report is for one (1) synfix® evolution aiming device holder.This is report 1 of 1 for (b)(4).

• Brand Name: SYNFIX® EVOLUTION AIMING DEVICE HOLDER
• Type of Device: IMPACTOR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES HAEGENDORF GMBH-CN; im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8322130
• MDR Text Key: 136144579
• Report Number: 2939274-2019-56372
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: 10705034814100
• UDI-Public: (01)10705034814100
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.835.004
• Device Catalogue Number: 03.835.004
• Device Lot Number: L677300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2017
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1